Stivarga approved for advanced gastrointestinal stromal tumors
FDA expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. More informationFDA alerts health care providers of recall of anemia drug Omontys
FDA is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients. More information
Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection
Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (Takeda) have decided to voluntarily recall all lots of OMONTYS® (peginesatide) new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. More information
Comunicaciones 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
For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.
FDA 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 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:
Alteplase (Cathflo Activase)
Hydromorphone Hydrochloride Tablets
Methylphenidate Hydrochloride Tablets
Methylphenidate Hydrochloride ER Tablets
Methylin Chewable Tablets
Drugs to be Discontinued Announced During Past 2 Weeks:
Cefuroxime Sodium
Lisinopril and Hydrochlorthiazide (Prinzide) Tablets
Osphena approved for postmenopausal women experiencing pain during sex
FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. Dyspareunia is a condition associated with declining levels of estrogen hormones during menopause. Less estrogen can make vaginal tissues thinner, drier and more fragile, resulting in pain during sexual intercourse. More informationNew silicone gel-filled breast implant approved
The FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc. The FDA based its approval on seven years of data from 941 women. More information
New treatment for late-stage breast cancer approved
FDA approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival. More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
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: Food and Drug Administration Drug Shortages Task Force and Strategic Plan
To assist FDA in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages. Comments are due by March 14, 2013. More information
Request for Comments: Draft Guidances for Industry on Abuse-Deterrent Opioids – Evaluation and Labeling
This draft guidance is intended to provide industry with a framework for evaluating and labeling abuse-deterrent opioid products. The draft guidance discusses how the potentially abuse-deterrent properties of an opioid analgesic formulated to deter abuse should be studied, specifically addressing in vitro studies, pharmacokinetic studies, human abuse potential studies, and postmarket studies. The draft guidance also describes the types of information and claims that may be suitable for inclusion in labeling. Comments are due by March 15, 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 March 18, 2013. More information
Request for Comments: Draft Guidance for S10 Photosafety Evaluation of Pharmaceuticals
FDA is announcing the availability of a draft guidance entitled “S10 Photosafety Evaluation of Pharmaceuticals.” The draft guidance was prepared under the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. Comments are due by March 21, 2013. More information
Request for Comments: Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis
FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS. Comments are due by March 25, 2013. More information
Request for Comments: Clinical Flow Cytometry in Hematologic Malignancies
FDA is announcing the following public workshop entitled “Clinical Flow Cytometry in Hematologic Malignancies.” The purpose of this public workshop is to seek public input from academia, Government, laboratorians, industry, clinicians, patients and other stakeholders on the role of clinical flow cytometry in hematologic malignancies, in order to develop a specific regulatory policy for this class of in vitro diagnostic devices. Comments are due by March 29, 2012. More information
Request for Comment: Smokeless Tobacco Product Warning Statement
FDA is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products. Comments are due by April 1, 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
Request for Comments: Draft Guidance for Industry on Alzheimer’s Disease – Developing Drugs for the Early Stage Disease
This guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer’s disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA’s current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. Comments are due by April 9, 2012. More informationRequest for Comments: Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
FDA is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute’s approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements. Comments are due April 18, 2013. More information
Request for Comments: Draft Guidance for Industry and FDA Staff – Providing Information About Pediatric Uses of Medical Devices
This proposed rule would require each applicant who submits an humanitarian device exemption, premarket approval (PMA), supplement to a PMA, or product development protocol to include, if “readily available,” a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. FDA is proposing to codify a definition of “readily-available” and also issue a draft guidance document to explain the Agency’s current thinking on the meaning of “readily-available information” and how to comply with the requirements set forth in section 515A of the FD&C Act. Comments are due by April 22, 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 May 13, 2013. More information
Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety
FDA 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. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. Comments are due by May 16, 2013. More information
FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events
The FDA is seeking input from industry and the public on the effects of extreme weather and natural disasters on the production and supply of medical devices. The FDA will use the information to identify steps that the agency, manufacturers, and the public can take to prepare for such events. More information
FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines, by: Margaret A. Hamburg, M.D., Commissioner FDA
More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs.FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the U.S., becoming a major public health challenge. While much of the problem is attributable to illicit use which can include sharing medication with family and friends or theft of the drug from home medicine cabinets, legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. Our nation’s front-line health care professionals, especially physicians and other prescribers can play an important role in efforts to reduce this trend. To read the rest of this blog, see FDA Voice Blog, March 1, 2013.
Rare Disorders Without Borders: An International Strategy, by: Katherine Needleman, Ph.D.
The development of 200 new therapies for rare diseases and diagnostic tests for most rare diseases would alleviate untold suffering. So with great enthusiasm, FDA’s Office of Orphan Products Development (OOPD) has joined a global effort to make those goals a reality by 2020.
These are the goals of the International Rare Disease Research Consortium (IRDiRC), launched by the European Commission and the U.S. National Institutes of Health in April 2011 to foster collaboration in rare disease research. FDA’s OOPD recently joined IRDiRC’s Executive Committee. When the consortium holds its first major conference in Dublin in April, top experts and researchers from around the world will share information and foster collaborations.
We’re Taking Steps to Enhance the Safety of Cantaloupe for Consumers, by: Michael M. Landa
The growing and harvest season for cantaloupe in the United States is beginning and FDA is working with its state partners and the produce industry to make sure that this is a good, safe year for lovers of this nutritious fruit. As FDA works on implementing the produce safety standards mandated by the FDA Food Safety Modernization Act, it is essential that those involved in growing, harvesting, and distributing cantaloupe – and produce in general – follow agricultural practices that FDA and the produce industry have identified as effective in minimizing the risk of contamination. FDA is now issuing a letter to firms that handle cantaloupe to help reduce the chance that the fruit may be contaminated by harmful bacteria. Our letter has two key messages. To read the rest of this blog, see FDA Voice Blog, February 25, 2013
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.
POSTPONED Pulmonary-Allergy Drugs Advisory Committee Meeting
Date: March 7, 2013
Transmissible Spongiform Encephalopathies Advisory Committee Meeting
Date: March 14, 2013
The committee will meet in open session to discuss FDA’s draft risk assessment model for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in Red Blood Cells for transfusion in the United States. More information
Pediatric Advisory Committee Meeting
Date: March 14, 2013
The committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Acterma (tocilizumab), Alimta (pemetrexed disodium), Creon (pancrelipase), Gadavist (gadobutrol), Hizentra [Immune Globulin Subcutaneous (Human), 20% Liquid], Inomax (nitric oxide), Invega (paliperidone), Kedbumin (albumin human), Kytril Injection (granisetron hydrochloride), Lamictal XR (lamotrigine), Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine], Moxeza (moxifloxacin ophthalmic solution 0.5%), Natroba (spinosad), Nexium (esomeprazole magnesium), Nexium IV (esomeprazole sodium), Uroxatral (alfuzosin hydrochloride), and Zenpep (pancrelipase). Also, there will be an Informational Update on Codeine. More information
Neonatal Subcommittee of the Pediatric Advisory Committee Meeting
Date: March 15, 2013
The committee will convene a non-voting session to establish an operational framework for the subcommittee as well as discuss and comment on nonspecific matters pertaining to neonatology. The subcommittee will also comment on ways to approach the challenges and identify different programmatic strategies for advancing the knowledge necessary to developing neonatal regulatory science. More information
Public Workshop: Third Party Governance of Industry-Sponsored Tobacco Product Research
Dates: March 19-20, 2013
The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research. More informationCirculatory System Devices Panel of the Medical Devices Advisory Committee Meeting
Date: March 20, 2013
The committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. More information
Public Conference: Detecting and Evaluating Drug Induced Liver Injury – What’s Normal, What’s Not, and What Should we do about It?
Dates: March 20-21, 2013
The purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose. More information
Psychopharmacologic Drugs Advisory Committee Meeting
Date: March 21, 2013
The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence. More information
Public Workshop: Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop
Date:March 22, 2013
This workshop will provide a forum to discuss issues related to breast cancer drug development in the neo-adjuvant setting. The topics will include: (1) how Neoadjuvant trials can expedite drug development, (2) the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis results, and (3) the draft FDA Guidance for Industry: Use of Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early Stage Breast Cancer as an Endpoint to Support Accelerated Approval. More information
Orthopedic 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
Ophthalmic Devices Advisory Committee Meeting
Date: April 8, 2013
The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. More information
Device Good Manufacturing Practice Advisory Committee Meeting
Date: April 11, 2013
The committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA’s current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. More information
Medical Devices Advisory Committee Meeting Date: April 25-26, 2013
On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. More information
On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. More information
Public Workshop: Accessible Medical Device Labeling in a Standard Content and Format
Dates: April 29-30, 2013
The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling. More information
Oncologic Drug Advisory Committee Meeting
Date: May 2, 2013
During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma.During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. More information
Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee Meeting
Date: May 3, 2013
The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) More information
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.
6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams
You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “revolutionary scientific breakthrough,” or “alternative to drugs or surgery.”
Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer.
According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose. To read the rest of the article, see Consumer Updates.
Don’t Get Scammed: Beware of Health Fraud National Consumer Protection Week runs March 3–9, 2013. This coordinated campaign by federal, state, county and local government agencies, and non-profit partner organizations encourages consumers nationwide to make better-informed decisions.
In this video, the Commissioner of Food and Drugs Margaret A. Hamburg, M.D., and the FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud scams and give tips to consumers. Posted on March 5, 2013 by FDA Voice
Generic Drugs: Same Medicine, Lower Cost
Perhaps you’ve had this experience: You go to your local pharmacy to buy medicine. You’re inclined to go with the familiar brand name product, the one you know from commercials and other advertising. But the generic version is much less expensive.”If it’s so inexpensive, it must not be as effective or safe,” you think. You would be wrong.
You’re not alone. FDA pharmacist Brenda Stodart, Pharm.D., who for 14 years has answered questions on FDA’s Drug Information line (1-855-543-DRUG ) says, “Every day without fail we educate consumers and health care professionals about the safety and efficacy of generic drugs.”
5 Things to Know About Breast Implants
Should I get breast implants? Are there alternatives? Will they need to be replaced?
And if you decide to get implants, there are even more questions. Saline or silicone? What style? How much monitoring is needed?Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision. To read the rest of the article, see Consumer Updates
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
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 informationFDA 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
Have 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
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
Tobacco Products
The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. More informationTobacco 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
Center 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 facts for consumers to keep you and your family safe. More information
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Los Angeles County Registrar-Recorder/County Clerk (RR/CC) Dean C. Logan announced the seventh post-Election Night ballot count update for the Nov. 5, 2024 General Election.
Mission Opera will present its Fifth Annual Winter Holidays of the World, a free concert for residents of the Santa Clarita Valley and surrounding areas, featuring a celebration of international winter holidays through music and dance.
The Santa Clarita Valley Chamber of Commerce has announced its annual 2025 Employment Law Update, taking place on Thursday, Jan. 23, at the College of the Canyons University Center.
Los Angeles County Registrar-Recorder/County Clerk (RR/CC) Dean C. Logan announced the seventh post-Election Night ballot count update for the Nov. 5, 2024 General Election.
A partnership formed by the County of Los Angeles and leading Los Angeles philanthropic organizations have announced the formation of the Los Angeles County Office of Food Equity.
Mission Opera will present its Fifth Annual Winter Holidays of the World, a free concert for residents of the Santa Clarita Valley and surrounding areas, featuring a celebration of international winter holidays through music and dance.
The Santa Clarita Arts Commission will hold its regular meeting Thursday, Nov. 14, at 6 p.m., in Council Chambers at City Hall, 23920 Valencia Blvd., 1st Floor, Santa Clarita.
The city of Santa Clarita’s Film Office has released the list of nine productions currently filming in the Santa Clarita Valley for the week of Monday, Nov. 11 to Sunday, Nov. 17.
They made it hard on themselves, but The Master's University's women's volleyball team defeated the Life Pacific Warriors in the final match of the season to win the GSAC Women's Volleyball regular season championship on Friday, Nov. 8.
The Small Business Development Center is offering a free Restaurant Academy online webinar on how to "Start a Food Business in Your Home: The NEW Microenterprise Home Kitchen Operator."
College of the Canyons is sending both its cross country teams to the state championship meet for a second straight season after the Cougars posted a pair of successful runs at the 3C2A Southern California Regional Championships at Chaffey College on Friday, Nov. 8.
Golden Years Dog Sanctuary welcomes all to its Sit or Stroll open house, adoption event and fundraiser, noon-3 p.m. Saturday, Nov. 16 at 12682 Kagel Canyon Road, Sylmar, CA 91342.
The Castaic Union School District will hold its regular meeting Thursday, Nov. 14 at the District Office, located at 28131 Livingston Avenue in Valencia. A closed session will begin at 5:30 p.m., followed by an open session at 6 p.m., where there will be a report of closed session action.
Join Hart show Choir performers on an interactive journey through a holiday classic with Rudolph the Red-Nosed Reindeer 2-7 p.m., Saturday, Dec 7 and Sunday, Dec. 8 at the Hart High School cafeteria, 24825 Newhall Ave., Santa Clarita, CA 91321.
Heading into their games on Friday, Nov. 8, three Foothill League football teams had hopes for deep playoff runs. Valencia and Hart had their hopes dashed, but Golden Valley won, and will play on.
Placerita Canyon Natural Area will host the Mojave Desert Burrowers and Survival event Sunday, Nov. 17 from 2-3 p.m. at 19152 Placerita Canyon Road, Newhall, CA 91321.
The Future Farmers of America will host a Christmas Tree Sales Fundraiser Festival in Frazier Park one weekend only on Saturday, Nov. 30 and Sunday, Dec. 1.
The College of the Canyons Athletics Department invites community members of all ages to run, walk or jog in the 16th annual Thanksgiving Day 'Turkey Trot' event benefiting the college's cross country and track & field programs 8 a.m. Thanksgiving Day, Thursday, Nov. 28 at College of the Canyons Valencia Campus, 26455 Rockwell Canyon Road, Santa Clarita, CA 91355.
The Santa Clarita Community College District Board of Trustees will hold a business meeting Wednesday, Nov. 13, beginning at 5 p.m. The board will first meet in closed session at 3 p.m.
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Stivarga approved for advanced gastrointestinal stromal tumors
FDA 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.
Osphena approved for postmenopausal women experiencing pain during sex
Request for Comments: Draft Guidance for Industry on Alzheimer’s Disease – Developing Drugs for the Early Stage Disease
FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events
FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines, by: Margaret A. Hamburg, M.D., Commissioner FDA
We’re Taking Steps to Enhance the Safety of Cantaloupe for Consumers, by: Michael M. Landa
Public Workshop: Third Party Governance of Industry-Sponsored Tobacco Product Research
Oncologic Drug Advisory Committee Meeting 
6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams
Generic Drugs: Same Medicine, Lower Cost
5 Things to Know About Breast Implants
Device Use Safety Tips
Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
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