January 14, 2015

ANNOUNCEMENTS

FDA Drug Info Rounds Video: Disposal of Unused Medicines What do patients do with medications that have not been used or are out of date? FDA Drug Info Rounds pharmacists discuss medication disposal options and some special disposal instructions for your patients to consider when throwing out expired, unwanted, or unused medicines. More information

Medscape Expert Interview Series: FDA Updates Labels for Pregnant and Breastfeeding Women

In this interview with Medscape, FDA experts Melissa S. Tassinari, PhD, and Jeanine Best, MSN, RN, PNP, from the Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health, explain how the new labeling will help providers make more informed decisions.  More information

From our Perspective: Patients Deserve Quality Medications

Lawrence X. Yu, Ph.D., Acting Director of FDA’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, discusses the important roles of FDA and drug companies in ensuring quality drug products. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Comment Request: Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information.  More information

Comment Request: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events.  More information 

Comment Request: Evaluation of the Food and Drug Administration's Multicultural Youth Tobacco Prevention Campaigns

The 2009 Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves anti-clotting drug Savaysa FDA approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart valve problem. Savaysa also has been approved to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for five to ten days. More information

FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test

FDA granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

PRODUCT SAFETY

To receive MedWatch Safety Alerts by email subscribe here. For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch.

Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter pain medicines when used during pregnancy. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. More information

Virazole (Ribavirin Powder for Solution) by Valeant Pharmaceutical North America: Recall- Microbial Contamination

Valeant Pharmaceuticals North America LLC (VPNA) is issued a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level. 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 endruginfo@fda.hhs.gov. Comunicaciones de la FDA

UPCOMING MEETINGS

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. 

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

Anti-Infective Drugs Advisory Committee Meeting (Jan 22)

The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis. More information

FDA-AAPS-ACCP-ASCPT Co-sponsored Workshop - Evaluating and Modernizing our Approaches for Food-Effect Assessment (Feb 2-4)

The goals of this public workshop are to facilitate discussion on current scientific approaches on assessing the effect of food on the pharmacokinetics and pharmacodynamics of drugs, and to initiate constructive discussion and information sharing among relevant stakeholders on the influence of food-effects on the pharmacokinetic properties of therapeutics in order to optimize dose and dosing regimens. More information

Orthopaedic and Rehabilitation Devices Panel (Feb 20)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated.More information 

Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests (Feb 20)

The purpose of this workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology. More information

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (Feb 27)

The committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. More information

RESOURCES

MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information  

Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. 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 FDA Voice FDA voice is the official blog from FDA's senior leadership and staff.More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information