 Stivarga approved for advanced gastrointestinal stromal tumorsFDA 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 |
 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 recogni es 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.
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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 Hydrochlorthia ide (Prin ide) Tablets
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 Osphena approved for postmenopausal women experiencing pain during sexFDA 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 si e (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 |
 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 Request for Comments: Draft Guidance for Industry and FDA Staff – Design Considerations for Devices Intended for Home Use |
 | 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 Harmoni ation (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 minimi ing 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 Al heimer’s Disease – Developing Drugs for the Early Stage DiseaseThis guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Al heimer’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 summari ing 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
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Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety |
 FDA seeks input on minimi ing disruptions to medical device supply chain during extreme weather eventsThe 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 organi ations in encouraging prescribers to seek training to safely prescribe opioid pain medicines, by: Margaret A. Hamburg, M.D., Commissioner FDAMore 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. 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. To read the rest of this blog, see FDA Voice blog, February 28, 2013 |
 We’re Taking Steps to Enhance the Safety of Cantaloupe for Consumers, by: Michael M. LandaThe 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 Moderni ation 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 minimi ing 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 Creut feldt-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 (tocili umab), Alimta (pemetrexed disodium), Creon (pancrelipase), Gadavist (gadobutrol), Hi entra [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], Moxe a (moxifloxacin ophthalmic solution 0.5%), Natroba (spinosad), Nexium (esomepra ole magnesium), Nexium IV (esomepra ole sodium), Uroxatral (alfu osin hydrochloride), and enpep (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 ResearchDates: 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 si ed, 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? Psychopharmacologic Drugs Advisory Committee Meeting Public Workshop: Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting |
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
Medical Devices Advisory Committee Meeting On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isonia id test strips. Isonia id 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 |
 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 tivo anib 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 Melble Kit (Melble (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 |
 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 ScamsYou’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
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 For More Information:
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 Generic Drugs: Same Medicine, Lower CostPerhaps 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.” To read the rest of the article, see Consumer Updates or for more facts about generic drugs |
 5 Things to Know About Breast ImplantsShould 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 TipsMedical 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 Educational Videos About FDA
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 Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDAFDA 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. |
 Animal Health LiteracyAnimal 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 |
 Tobacco ProductsThe 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
Product Safety News from the FDA
