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October 18
1876 - Southern Pacific begins subdividing town of Newhall (original location at Bouquet Junction) [story]



Product Safety Bar

F&PFisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall – Pinholes in Tubes
FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the tubes used in the reusable breathing circuit. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Usage of the defective device may result in patient death.
More information
Nurse using an IpadMedication Guides for Certain Prescription Medicines
The FDA wants you to know the importance of reading Medication Guides—paper handouts that come with many prescription medicines. “The information in a Medication Guide is very important when it comes to getting the most benefit for your health from a medicine,” says Paul Seligman, M.D., M.P.H., former Associate Director for Safety Policy and Communication in FDA’s Center for Drug Evaluation and Research. “These guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. To continue reading this Consumer Update or for more information about currently FDA approved Medication Guides.

 

 

 

burgandy fingerComunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA
MedWatch ImageFor more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.

 


Product Short and DC

Syringe and vialsFDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing and quality problems, delays, and discontinuations. When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients.  FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients.
More information

 

Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:

 

  • No current shortages reported

 

Drug Shortages Resolved During the Past 2 Weeks:

 

  • No current shortages resolved

 

Drugs to be Discontinued Announced During Past 2 Weeks:

 

  • Chloral Hydrate (Somnote) soft gel capsule

 

 

 

 

 

 

finger

 


Product Approval Bar

Blood Clot Eliquis approved to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
FDA approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
More information
Lungs-TB Med picSirturo approved to treat multi-drug resistant pulmonary tuberculosis
FDA approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. TB is an infection caused by Mycobacterium tuberculosis and is one of the world’s deadliest diseases. It is spread from person to person through the air and usually affects the lungs, but it can also affect other parts of the body such as the brain and kidneys.  More information

Fulyzag approved as first anti-diarrheal drug for HIV/AIDS patients
FDA approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. More information

Drugs@FDAFor information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

Comments and Guidances

FDA CDRH Logo BlackGuidance Documents on MDUFA III
The Food and Drug Administration Safety and Innovation Act (Public Law 112-144) includes the Medical Device User Fee Amendments of 2012, or MDUFA III. MDUFA III will take effect on October 1, 2012 and will sunset in five years on October 1, 2017.  Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. The FDA are issuing a series of guidance documents that help explain key provisions of MDUFA III. These guidance documents include 3 new guidance’s dated December 31, 2012.

Request for Comments: Framework for Pharmacy Compounding – State and Federal Roles
FDA is soliciting either comments on the issues discussed in section II of this document. Comments are due by January 18, 2013. More information

 

Request for Comments: Custom Devices
FDA is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption. FDA is seeking information on and examples of appropriate uses of the custom device exemption identified in section 520(b) of the FD&C Act. FDA encourages all stakeholders, including patients, physicians, dentists, and manufacturers, to submit comments on the appropriate use of this statutory provision. Comments are due by January 18, 2013.
More information

 

nurse using an electronic tablet 

Request for Comments: Draft Guidance for Industry – Electronic Source Data in Clinical Investigations
FDA is announcing the availability of a draft guidance for industry entitled “Electronic Source Data in Clinical Investigations.” This document revises and updates the draft guidance entitled “Electronic Source Documentation in Clinical Investigations.” This revised draft document provides guidance to sponsors, CROs, data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. Comments are due by January 22, 2013. More information

 

Request for Comments: Draft Guidance for IRBs, Clinical Investigators, and Sponsors – IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed
This draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations. Comments are due by January 22, 2013.
More information

 

 

Draft Guidances for Industry: Safety Considerations for Product Design to Minimize Medication Errors
This draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. Comments are due by February 11, 2013.
More information

 

Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds
Food allergy is an immune-mediated sensitivity to foods that can lead to life-threatening adverse reactions. Because there is no cure for food allergy, allergic consumers must use avoidance to prevent allergic reactions. Successful avoidance requires, among other things, that allergic consumers and their caregivers be able to read and understand the ingredient lists on packaged foods. Comments are due by February 12, 2013. More information

Request for Comments: Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
FDA is announcing the availability of a draft guidance for industry entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Comments due by February 15, 2013. More information

Open GovernmentRequest for Comments: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Comments are due by February 15, 2013. More information

 

 

 

 

Request for Comments Date Extended: Information on Nicotine Replacement Therapies and Smoking-Cessation Products
FDA is extending the comment period for the notice of public hearing that appeared in the Federal Register of November 28, 2012 (77 FR 70955). In the public hearing notice, FDA requested comments on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. The Agency is taking this action to allow interested persons additional time to submit comments. More information

 

HIV Ribbon and Pill 

Request for Comments: Draft Guidance for Industry – Development of Vaginal Microbicides for the Prevention of Human Immunodeficiency Virus Infection
FDA is announcing the availability of a draft guidance for industry entitled ‘‘Vaginal Microbicides: Development for the Prevention of HIV Infection.’’ The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides.Comments are due by February 21, 2013.
More information

 

Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy and Public Workshop
FDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. To attend workshop, registration is required by February 1, 2013. Comments are due by March 11, 2013.More information

 

Request for Comments: Draft Guidance for Industry and FDA Staff – Design Considerations for Devices Intended for Home Use
FDA is announcing the availability of the draft guidance entitled “Design Considerations for Devices Intended for Home Use.” This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Comments are due by March 13, 2013. More information

Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy
FDA invites comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. Comments are due by April 8, 2013. More information


Announcements Bar

Joe and the horseDrug Residue in our Food Supply
Illegal drug residues in the nation’s food supply are a concern to the Food and Drug Administration. The Center for Veterinary Medicine’s Division of Compliance is responsible for reviewing violative residues reported to the Agency by the USDA’s Food Safety and Inspection Service. The residues are ranked using a Risk Model to ensure Federal and/or State investigation of the residues of greatest public health concern for which assignments are issued. The Drug Residue Compliance Team provides regulatory support and outreach to prevent illegal drug residues by reviewing inspectional evidence sent to us by the FDA District Offices. More information
 

FDA Provides a Portal to India
The next time you stir black pepper, cumin, chili or cardamom into your stew, think about this: Nearly one quarter of the spices, oils and food colorings used in the United States comes from India. In fact, India is the largest producer, consumer and exporter of spices globally. But that’s not all. India is an important source of trade with the U.S. In 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S. The FDA works hard to make sure that these India-produced foods and drugs are safe, effective and of good quality. More information

India
Food SafetyFDA proposes new food safety standards for foodborne illness prevention and produce safety
The U.S. Food and Drug Administration today proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules. More information

New Drug Attacks Resistant TB by Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration
Having seen first-hand the threat to public health posed by multi-drug resistant tuberculosis (MDR TB), which cannot be cured by many of the most powerful drugs usually used to treat the disease, I’m pleased that another weapon has been added to the arsenal for fighting this deadly, contagious disease. To continue reading this blog, see FDA Voice Blog, December 31, 2012.

 

FDA Commemorates 30th Anniversary of the Orphan Drug Act By Gayatri R. Rao, M.D., J.D., Director for The Office of Orphan Products Development
When President Reagan signed the Orphan Drug Act 30 years ago, he enacted a critically important piece of health care legislation. The passage of this Act on January 4, 1983, was monumental because it created—for the first time—incentives to develop desperately needed medical products for Americans suffering with rare diseases. Until that point, development of such products was very limited. For instance, in the decade leading up to the passage of the Orphan Drug Act, only 10 industry-supported products for rare diseases were brought to market. To continue reading this blog, see FDA Voice Blog, January 7, 2013
Gayatri Rao

Basing Food Safety Standards on Science and Prevention By Margaret Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration
Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply. That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce. The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. To continue reading this blog, see FDA Voice Blog, January 8, 2013


Cord Blood Banking – Information for Consumers
Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood? Here is some information for expectant parents about the regulations in place designed to help ensure the safety of cord blood for transplantation. To continue reading this information for consumers


Ucoming Meetings Bar

FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees. Click on “More information” for details about each meeting.

January 2012

older adults joggingEndocrinologic and Metabolic Drugs Advisory Committee Meeting
Date: January 10, 2013
The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. More information

 

 

 

Cellular, Tissue and Gene Therapies Advisory Committee Meeting
Date: January 15, 2013
On January 15, 2013 from 2 p.m. to approximately 4:30 p.m., the Committee will meet, by teleconference, in open session, to hear updates on the research programs in the Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA.  From approximately 4:30 p.m. to 5:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).  The committee will discuss reports of the intramural research programs and make recommendations regarding personnel staffing decisions. More information

 

Drug Safety and Risk Management Advisory Committee Meeting
Dates: January 24-25, 2013
The committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II. More information

InhalerPulmonary-Allergy Drugs Advisory Committee Meeting
Date: January 29, 2013
The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. More information

 

Pulmonary-Allergy Drugs Advisory Committee Meeting
Date: January 30, 2013
The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function. More information

February

 

Public Hearing: Impact of Approved Drug Labeling on Chronic Opioid Therapy
Dates: February 7-8, 2013
Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. The July 9, 2012, approval of the Risk Evaluation Management Strategy for extended-release (ER) and long-acting (LA) opioid analgesics is a recent example of FDA’s ongoing commitment to ensuring that the benefits of these types of opioid drugs continue to outweigh their risks. More information

 

 

Public Workshop: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy
Dates: February 11-12, 2013
FDA is announcing this public workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. More information

 

Risk Communication Advisory Committee Meeting
Date: February 12, 2013
The committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception. More information

 

x rayMedical Imaging Drugs Advisory Committee Meeting
Date: February 14, 2013
The committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation). More information

 

Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
Date: February 22, 2013
The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information

March

 

Reproductive Health Drugs Advisory Committee Meeting
Date: March 4, 2013
The morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause. During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopause. More Information

Pulmonary-Allergy Drugs Advisory Committee Meeting
Date: March 7, 2013
The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information

April

 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
Date: April 5, 2013
The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.More information

finger

Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

Consumer Update bar

Nutrition Fact labelNutrition Facts Label: 20 and Evolving
When you’re walking down the aisles of a supermarket, it’s not unusual to see fellow shoppers reading the information on the back of a food package, box or can. They might want to know how many calories are in the food, or they might be watching their sodium intake.

 

They could be trying to limit sugars and eat more dietary fiber. Or they could be parents trying to make the most nutritious choices for their children.

 

All this information is available thanks to an important addition to food packaging that was introduced to the American public 20 years ago: the Nutrition Facts label. This familiar rectangular box provides, in a standard format, important information about the nutritional content for most packaged foods, including breads, cereals, canned and frozen foods, snacks, desserts and drinks. More information

FSMA FrameworkFDA Strengthening our Food Safety Foundation
For the FDA, prevention is at the heart of food safety. “Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” says FDA Commissioner Margaret A. Hamburg, M.D. “We cannot afford to wait until people become ill to realize there is a problem.”  Prevention is the core principle of the FDA Food Safety Modernization Act that President Obama signed into law in 2011, creating a blueprint for the most sweeping changes to the nation’s food protection system since Theodore Roosevelt held office. More information
Woman looking at a pill bottle 

Understanding Antidepressant Medications
Depression affects about 121 million people worldwide and is a leading cause of disability, according to the World Health Organization (WHO). “In my experience as a practicing psychiatrist, I’ve seen that many people with depression don’t realize that they have the condition or that it’s treatable,” says Mitchell Mathis, M.D., deputy director of the Division of Psychiatry Products at the FDA. Some who suffer from depression don’t recognize the symptoms, or they attribute them to lack of sleep or poor diet.
More information

More Consumer Updates
For previously published Consumer Update articles that are Timely and easy-to-read and cover all FDA activities and regulated products. More information

Artículos en Español
Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable. More information


Resources

FDA On line Resource 

Device Use Safety Tips
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. More information

 

FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

 

Janet WoodcockHave a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity. More information

 

 

To read questions and answers, see MailBag.


Jack 9 months old 

 

Animal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information

CVM Pet Facts
The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe.
More information


Food SafetyCenter for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of the Food and Drug Administration (FDA). The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics.
More information

 

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food fact for consumers to keep you and your family safe. More information


FDA and CigaretteTobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics. More information

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SCV NewsBreak
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LOCAL NEWS HEADLINES
Tuesday, Oct 17, 2017
Rick Gould Retires as City’s Parks & Recreation Chief
After 16 years as director of Parks, Recreation and Community Service for the city of Santa Clarita, Rick Gould announced Monday he's retiring in mid-December.
Tuesday, Oct 17, 2017
National Teen Driver Safety Week Underway
Motor vehicle collisions are the leading cause of death for teenagers, ahead of all other types of injury, disease, or violence.
Tuesday, Oct 17, 2017
Resources, Outreach Available to SCV Victims of Elder Abuse
Elder abuse and scams targeting seniors are a growing problem, Santa Clarita detectives said, but there are numerous resources and protections available.
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Latest Additions to SCVNews.com
1876 - Southern Pacific begins subdividing town of Newhall (original location at Bouquet Junction) [story]
CalArts Center for New Performance (CNP), the professional producing arm of California Institute of the Arts, opens Fantômas: Revenge of the Image at Wuzhen Theatre Festival in Wuzhen, China, on Oct. 19.
Oct. 19: CalArts’ Fantomas: Revenge of the Image Premieres in China
The CSUN women's golf team fired rounds of 306-309 and is in fourth place, just eight shots off the pace at the Pat Lesser Harbottle Seattle University Invitational at the Tacoma Country and Golf Club in Tacoma, WA.
CSUN Just Eight Shots Off Pace At Washington Invitational
Tonight on SCV NewsBreak, Recreation, Community Services, Arts and Open Spaces Director Rick Gould announces retirement. Plus, the Board of Supervisors approve mental health care improvements. Check out these stories and more tonight on SCV NewsBreak.
SCV NewsBreak for Tuesday, October 17, 2017
The Advanced Technology Presentation about "Careers in the Making...Design, Engineering, Fabrication and More..." in celebration of National Manufacturing Day was a huge success.
SCV Students Gain Knowledge, Advice at National Manufacturing Day
A local company is expanding its footprint in the Santa Clarita Valley to accommodate business growth and another is relocating a division of its company from Sylmar.
Accurate Freight Systems Expands, Leases Space at IAC Commerce Center
The Domestic Violence Center (DVC) of Santa Clarita Valley is accepting applications for Adopt-a-Family 2017.
DVC of SCV Currently Accepting Adopt-a-Family 2017 Applications
Major Impact Theater, founded by Jill Garson and Shawnda Davis in 2014, is a non-profit theater group that specially adapts plays for performance by adults with disabilities in the Santa Clarita Valley.
Nov. 4: Major Impact Theater Presents Blunderland
California State University, Northridge will make history on Thursday, Oct. 26, by becoming the first California State University with a Sustainability Center.
Oct. 26: CSUN to Open Sustainability Center
Registration for the Purple Walk of Strength is now open.
Oct. 21: Purple Walk of Strength to Benefit Domestic Violence Center
Raising a child is a demanding job for any parent, especially when supportive resources seem to be elusive or nonexistent.
Oct. 22: CSUN Hosts Special Needs Resource Fair
College of the Canyons dominated its match vs. Bakersfield College from start to finish on Friday night, resulting in a 5-1 victory over the Renegades for the Cougars' first conference win of the season.
COC Gets First Conference Win of Season Against Bakersfield College
RIVERSIDE, Calif. — Following a two-week layoff, College of the Canyons cross country was back in competition on Saturday, running with a mix of community college and Division I programs at the Sixth Annual UC Riverside Highlander Invitational.
COC Cross Country Back in Competition After Two Week Layoff
The race to qualify for the Big West Conference Men's Soccer Tournament continues for CSUN this week with a home match against UC Riverside Wednesday night before the Matadors head to UC Irvine Saturday.
Oct. 18: CSUN Faces Off Against UC Riverside
After 16 years as director of Parks, Recreation and Community Service for the city of Santa Clarita, Rick Gould announced Monday he's retiring in mid-December.
Rick Gould Retires as City’s Parks & Recreation Chief
High school seniors whose dream is to make a difference in the world by majoring in science, technology, engineering or math (STEM) are invited to apply for Edison International’s $1.2 million Edison Scholars Program.
STEM Students Encouraged to Apply for Edison Scholars Program
Motor vehicle collisions are the leading cause of death for teenagers, ahead of all other types of injury, disease, or violence.
National Teen Driver Safety Week Underway
Elder abuse and scams targeting seniors are a growing problem, Santa Clarita detectives said, but there are numerous resources and protections available.
Resources, Outreach Available to SCV Victims of Elder Abuse
Despite rallying from an early 2-0 deficit, College of the Canyons dropped a 4-2 decision to visiting Victor Valley College on Friday.
Canyons Rally Not Enough To Hold Off Victor Valley College
The College of the Canyons baseball program and Playa Vista Orioles youth baseball organization will host a free instructional clinic for players ages 11-14 from 10 a.m. to 2 p.m. Saturday, Oct. 21, at Cougar Field.
Oct. 21: Youth Baseball Clinic at COC
Sacramento – In an effort to curb the fraudulent use of Disabled Person Parking Placards, the California Department of Motor Vehicles (DMV) has launched a statewide public awareness campaign to educate Californians about the proper use of disabled parking placards and the consequences of misusing one.
DMV Launches Statewide Campaign on Use of Disabled Parking Placards
A California State University, Northridge program that provides support to undergraduate students from underrepresented communities to pursue graduate degrees in the mathematical sciences has been named a 2017 Example of Excelencia in Education.
CSUN Math Program Lauded 2017 Example of Excelencia in Education
RE/MAX of Valencia will be hosting a blood drive benefiting Children's Hospital Los Angeles.
Nov. 1: RE/MAX Blood Drive to Benefit CHLA
Princess Cruises has officially announced its third annual Culinary Cruise Series, featuring famed Miami-based chefs Brad Kilgore and Scott Linquist.
Princess Cruises Will Feature Two Acclaimed Chefs in Culinary Cruise Series
1837 - Trapper Peter LaBeck killed by grizzly bear at El Tejon [story]
Tonight on SCV NewsBreak, Governor Brown signed off on a new bill that will change local water retailers distribute water in SCV. Plus, a spicy and savory Saturday for charity. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Monday, October 16, 2017
The Newhall School District's next Regular Board Meeting is Tuesday, October 17 at 6:15 p.m., and consideration of Newhall Family Theater approvals are on the agenda.
Oct. 17: Newhall School District Considers Newhall Family Theater OK
Master’s and Westmont College needed more than 90 minutes again Saturday to settle a Golden State Athletic Conference showdown in Santa Barbara.
Master’s Men Soccer Players Fall to Westmont in OT
Leaders from the CLWA and NCWC will meet in October, November and December to discuss their merger, which creates the Santa Clarita Valley Water Agency as of Jan. 1.
Next Step: Water Agency Officials to Share Merger Details
Master’s women soccer players and coaches alike were adamant after Saturday’s top-10 matchup that Westmont’s 5-2 win wasn’t nearly as lopsided as the score suggests.
Westmont Tops Master’s Women’s Soccer 5-2
Although Friday the 13th is a day generally associated with bad luck, CalArts turned the superstition on its ear as the community celebrated the inauguration of its fourth president, Ravi S. Rajan.
CalArts Inaugurates Ravi S. Rajan as Fourth President
CalArts School of Theater faculty Janie Geiser brings her collage film program "Double Vision" to REDCAT in downtown Los Angeles on Monday, Oct. 16 at 8:30 p.m.
Oct 16: ‘Double Vision’: Recent Films by Janie Geiser at REDCAT
The promising signs the Mustangs showed in their Missouri opener paid off in the evening Friday when Master’s women’s volleyball picked up its first road win of the season.
Master’s Rallies on the Road, Nets Season’s First Win
College of the Canyons' women's volleyball team opened Western State Conference play in style, as the Cougars swept visiting West L.A. College in straight sets.
No. 11 Canyons Sweeps West L.A. at the Cougar Cage
Route 66 Classic Grill in Canyon Country will host a fundraiser for local victims of the October 1 Las Vegas shootings on Saturday, October 28, from noon to 4 p.m.
Oct. 28: Route 66 Hosts Benefit for Las Vegas Shooting Victims
A roundup of the Santa Clarita arts-related events for Oct. 16-20, 2017.
Oct. 16-20: Santa Clarita Arts Upcoming Events