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October 17
1837 - Trapper Peter LaBeck killed by grizzly bear at El Tejon [story]


Product Safety Bar

Oxyelite ProUSPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
FDA announced  that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements.
More information
iclusigFDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales
FDA is providing instructions to health care professionals whose patients have been taking Iclusig (ponatinib) and are benefiting from the drug, on how to continue those patients on the drug. We are working closely with Iclusig’s manufacturer, ARIAD Pharmaceuticals (ARIAD), to avoid interruptions in treatment.  At this time, Iclusig treatment may be continued for appropriate patients under an emergency Investigational New Drug (IND) application. More information. This information is a follow up to the FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales issued on October 31, 2013
drug shortagesFDA takes two important actions on drug shortages
FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.  The announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing. More information 
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 Logo
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.

Product Short and DC

Drug ShortageFDA 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 issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, 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:

 

  • Tiopronin (Thiola)

 

Drug Shortages Resolved During the Past 2 Weeks:

 

  • Dexrazoxane Injection
  • Fluticasone Propionate and Salmetrerol (Advair HFA)

 

 

 

 

 

 

 

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Product Approval Bar

FDA ApprovedGazyva for chronic lymphocytic leukemia approved
FDA approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil, another drug used to treat patients with CLL.
Gazyva is the first drug with breakthrough therapy designation to receive FDA approval.
More information

Aptiom approved to treat seizures in adults
FDA approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain’s nerve cells. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year. Aptiom is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death.
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

Unique Device Identification System
FDA is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. More information

View current opportunities for comment on topics of interest for patients and caregivers.


Announcements Bar

E. ColiFDA Investigates Multistate Outbreak of E. coli O157 Illnesses Possibly Linked to Pre-packaged Salad Products 

janssen pharmaceuticalJanssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion. More information 
Janet Woodcock June 2013Working to improve the communication of important drug safety information about generic drugs, by: Janet Woodcock, M.D., Director of Center for Drug Evaluation and Research
FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA.

But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, and they can distribute that information before FDA has reviewed or approved the change. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible.

To read the rest of this blog, see FDA Voice Blog, November 8, 2013

 

Dr. Hamburg - Official photoPersonalized Medicine: The Future is Now, by Margaret A. Hamburg, M.D., Commissioner of FDA
The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients. 

Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

To read the rest of this blog, see FDA Voice Blog, November 1, 2013

personalized medicinePersonalized Medicine :FDA’s Unique Role and Responsibilities in Personalized Medicine
The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time.”   More broadly, “personalized medicine” may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.Consistent with FDA’s core mission, the agency is working in collaboration with researchers, manufacturers of drugs, medical devices and biologics, health care professionals and others to better understand and adapt to the promise of personalized medicine.  FDA’s ongoing efforts to make personalized medicine possible touch on various facets of product development and use including:


Ucoming Meetings Bar

Advisory Committee Meeting at FDAFDA 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.

View a complete list of upcoming public meetings and workshops.

 

 

fingerPlease 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

Types of transfatFDA Targets Trans Fat in Processed Foods
More than decade ago, a sea change began in the American diet, with consumers starting to avoid foods with trans fat and companies responding byreducing the amount of trans fat in their products.This evolution began when FDA first proposed in 1999 that manufacturers be required to declare the amount of trans fat on Nutrition Facts labels because of public health concerns. That requirement became effective in 2006. More information or to read press announcement.
teen lifitingTeens and Steroids: A Dangerous Combo
The abuse of anabolic steroids can cause both temporary and permanent injury to anyone using them. Teenagers, whose bodies are still developing, are at heightened risk. An alarming number of them are trying steroids in hopes of improving their athletic prowess or their appearance. Ali Mohamadi, M.D., a medical officer in the Food and Drug Administration’s Division of Metabolism and Endocrinology Products, warns teens and parents about the dangers of steroid use. More information
hearing lossHearing Loss Signals Need for Diagnosis
Straining to hear? Do people say you’re talking loudly? Thinking about ordering a hearing aid or sound amplifier from a magazine or late-night TV advertiser? 

Doing so could delay the diagnosis of a treatable or serious ear condition and lead to further hearing loss or other complications. “The problem might be as simple as a wax impaction blocking the ear canal, which is easily treated, or at the other end of the spectrum, it could be something as serious as a tumor pressing on the hearing nerve,” says Eric Mann, M.D., Ph.D., clinical deputy director for the Division of Ophthalmic, and Ear, Nose, and Throat Devices at FDA.
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. Artículos en Español


Food Safety Bar

holiday food safety Many people don’t realize that food safety is the most important ingredient in preparing food for the holidays. Below are some helpful food safety resources to keep your holidays happy:
Holiday Food Safety Success Kit
Holiday Food Safety Video
Ready-to-Cook Foods
Additional Information 
meeting for foodsGetting Importers’ Pulse About Food Safety Plans, from Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine
My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year. 

We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors – would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.

To read the rest of this blog, see FDA Voice Blog, November 4, 2013

 

Food SafetyCenter for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of 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


Animal Health Bar

dog playing frisbeePain Medicines for Pets: Know the Risks
Your 9-year-old German Shepherd is limping, and you think that arthritis may be setting in. A trip to the veterinarian proves that you’re right—it’s osteoarthritis, a degeneration of the cartilage and bone that affects joints. The veterinarian prescribes a non-steroidal anti-inflammatory drug (NSAID).NSAIDs are a class of drugs extensively used in both human and veterinary medicine for their anti-fever, anti-inflammatory and pain-relieving properties, and they are the most commonly prescribed pain relievers for animals. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs work by blocking the production of chemicals produced by the body that play a role in inflammation. More information
Dog with GlassesAnimal 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


Resources

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.

FDA On line ResourceFDA 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 informationEducational Videos
FDA Food Safety and Modernization Act: An FDA Primer
The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

 

healthfinder.govhealthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information 

Tobacco 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

 

 

 

 

 


Take me to the web site

An interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­– and medical devices move from the realm of idea to the realm of the marketplace. More information

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SCV NewsBreak
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LOCAL NEWS HEADLINES
Monday, Oct 16, 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.
Monday, Oct 16, 2017
Next Step: Water Agency Officials to Share Merger Details
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.
Monday, Oct 16, 2017
Oct. 28: Route 66 Hosts Benefit for Las Vegas Shooting Victims
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.
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Latest Additions to SCVNews.com
1837 - Trapper Peter LaBeck killed by grizzly bear at El Tejon [story]
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
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
The Santa Clarita Valley Chamber of Commerce's October mixer is set for Wednesday, October 18 at Atria Senior Living in Newhall starting at 5:30 p.m.
Oct. 18: SCV Chamber October Mixer at Atria
The Boys & Girls Club of Santa Clarita Valley will host a series of "Great Futures" tours for local residents in an effort to get the word out about the club's programs and services.
SCV Boys & Girls Club Hosts ‘Great Futures’ Tours
A special meeting of the Santa Clarita City Council, the Planning Commission, the Parks, Recreation and Communnity Services Commission, the Arts Commission, and the Open Space Preservation District Financial Accountability and Audit Panel is set for Tuesday, October 17 at City Hall.
Oct. 17: Harassment, Abusive Conduct Prevention Training for City Officials
The Hart Indians outscored the Canyon Cowboys 35-18 at Harry Welch Stadium Friday, October 13, in the teams' 50th matchup, and Kevin Karzin, president of the SCV Photographers Association, contributed photos from the game.
Photo Gallery: Hart Indians Beat Canyon Cowboys 35-18
Gov. Brown has vetoed a President Donald Trump-inspired proposal that would have required presidential candidates to release their tax returns in order to appear on the statewide ballot.
Brown Vetoes Bill Requiring Candidates Release Tax Returns
Gov. Jerry Brown signed a series of bills on Sunday calling for criminal justice reforms, including reduction of penalties for some gun and drug crimes and changes to the Megan's Law sex offender registry.
Brown Signs Bills for Criminal Justice Reforms
1853 - Sarah Gifford, community leader and wife of Newhall's first railroad station agent, born in England [story]
With the stroke of his pen Sunday, Gov. Jerry Brown eliminated the Castaic Lake Water Agency and Newhall County Water District and replaced them with a new water agency for the Santa Clarita Valley.
Brown Signs Wilk Bill Merging SCV Water Agencies
1939 - Second, larger OLPH Catholic Church dedicated on site of first (10th & Walnut, Newhall) [story]
Santa Clarita-based Princess Cruises celebrated the New York premiere of “Born to Dance,” the latest offering from its first-of-its-kind partnership with award-winning composer Stephen Schwartz and famed director/creator Daniel C. Levine.
Princess Cruises Celebrates NY Premiere of ‘Born to Dance’ With Schwartz, Levine
1980 - Phillies beat Royals in Game 1 of World Series; Hart grad Bob Walk is winning pitcher [story]
The Academy of Motion Picture Arts and Sciences honored 17 student winners from colleges and universities around the world at the 44th Student Academy Awards ceremony in Beverly Hills Thursday night.
Medalists Revealed at 2017 Student Academy Awards
The Los Angeles Dodgers will play host to the Chicago Cubs in Game 1 of the 2017 NLCS at Dodger Stadium on Saturday starting at 5:08 p.m.
National League Championships Open at Dodger Stadium Saturday
Santa Clarita ranks No. 5 among Los Angeles County's 88 cities in the assessed value of all taxable real property and business personal property, according to the 2017 Annual Report released by County Assessor Jeffrey Prang today.
Santa Clarita No. 5 Highest Valued City in LA County
The U.S. Attorney’s Office, the FBI, and a coalition of other law enforcement agencies and community organizations will host the 9th Annual Cyber Crime Prevention Symposium in downtown Los Angeles on Monday, October 16 from 8:25 a.m. to 1:45 p.m.
Oct. 16: Cyber Crime Symposium for Educators, Parents, Students
Tonight on SCV NewsBreak, locals found out what it is like to be a school principal. Plus, there are some great events to head out to this weekend. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Friday, October 13, 2017
Starting Monday night, Oct. 16, the California Department of Transportation will paint new temporary lanes on a section of Interstate 5 aka the Golden State Freeway in and near the city of Santa Clarita.
New Temporary Lanes Coming Monday on Interstate 5 in SCV
The William S. Hart Union High School District is looking for someone to become a personnel commissioner to serve a three-year term beginning December 1, 2017.
Hart District Seeks Personnel Commissioner for Classified Employees
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 at COC's Cougar Field in Valencia on Saturday, Oct. 21 from 10 a.m. to 2 p.m.
Oct. 21: COC Baseball, Playa Vista Orioles Youth Classic
An alumna of the Boys & Girls Club of Santa Clarita Valley, Cinthya Medrano, is the first recipient of a Duane R. Harte Memorial Scholarship.
Cinthya Medrano Earns First Duane R. Harte Memorial Scholarship
The non-profit Santa Clarita Coalition has created a Facebook page to aid the Evans family after the mother of six children died in a car crash on Golden Valley Road.
Facebook Page Created to Aid Evans Family
The Golden State Gateway Coalition, a non-profit transportation education and advocacy organization based in Santa Clarita, has published the fall 2017 edition of its newsletter, "Interchange."
Golden State Gateway Coalition Issues Fall 2017 Newsletter
The Castaic Lake Water Agency's Budget and Rates Committee is scheduled to meet on Tuesday, October 17 at 5:30 p.m.
Oct. 17: CLWA Budget and Rates Committee Meeting