ANNOUNCEMENTS

FDA takes several actions involving genetically engineered plants and animals for food

Based on sound science and a comprehensive review, the FDA is taking several important steps regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. More information

Lessons Learned in Mexico about Food Safety – And Tomatoes

Stephen M. Ostroff, M.D., Acting Commissioner of Food and Drugs and staff in FDA's Latin America Office met with regulatory counterparts in Mexico charged with keeping foods safe, and toured Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation in Mexico. In the process, he gained a new appreciation for the partnership we have with Mexico to enhance food safety and to minimize the potential for contamination of fresh produce. More information

CDER Perspective: Ensuring the safety and effectiveness of sunscreens

Theresa M. Michele, M.D., Director of FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products, discusses the changing pattern of sunscreen use and the need for additional safety data for sunscreen active ingredients that are not already included in the OTC sunscreen monograph. More information

A Mother’s Loss, an Advocate’s Example, Fuel Our Mission to Keep Foods Safe

Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, discusses his experience at the 2015 Food Safety Consortium in Schaumberg, Illinois, as well as the three Food Safety Modernization Act (FSMA) rules announced in November. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance for Industry on Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon

This document provides guidance intended to assist food manufacturers that wish to voluntarily label their food products or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon. FDA’s main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading. More information

FDA Issues 4 Draft Guidances for Industry on the Sunscreen Innovation Act

FDA is seeking stakeholder comments on four guidances on the Sunscreen Innovation Act. Stakeholders are encouraged to submit comments to the docket within the next 60 days. More information

PRODUCT APPROVALS & CLEARANCES

FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. More information

FDA approves Ninlaro, new oral medication to treat multiple myeloma

FDA approved Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. More information

FDA approves vaccine for use after known or suspected anthrax exposure

FDA approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. More information

FDA approves Opdivo to treat advanced form of kidney cancer

FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. More information

FDA approves Portrazza to treat advanced squamous non-small cell lung cancer

FDA approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. More information

FDA approves first seasonal influenza vaccine containing an adjuvant

FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older. More information

FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma

FDA granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. More information

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

PRODUCT SAFETY

Need Safety Information?

For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Drug Safety Communication: Clozapine - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program

Due to ongoing implementation challenges with the new Clozapine REMS Program, FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. FDA is also carefully evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch. FDA will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible. More information

Recall: Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd. - Inaccurate Temperature Display

Some Digital Temple Thermometers contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures, which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate care or receive more care than appropriate, when relying solely on the temperature display on the thermometer. More information

Recall: RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific - Wires May Break and Separate from the Rotablator System

Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause serious injury such as tamponade, myocardial infarction, and migration of wire fragments elsewhere in the body. The use of affected product may cause serious adverse health consequences, including death. More information

Voluntary Recall: Compounded Multivitamins by Glades Drugs - High Amounts of Vitamin D3 (Cholecalciferol)

The FDA has received reports of several adverse events potentially associated with compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol) made by Glades Drugs in Pahokee, Florida. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D levels may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention. More information

FDA Safety Communication: Intravascular Medical Devices - Lubricious Coating Separation

Hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes. Health care providers should be aware of potential problems and consider certain actions prior to use. More information

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.

FDA/American Society of Hematology Joint Symposium: Late-Breaking Drug Approvals (Dec 7)

At the 2015 American Society of Hematology (ASH) Annual Meeting, there will be an ASH/FDA Joint Symposium on Late-Breaking Drug Approvals at the Orange County Conference Center, Orlando, Florida. The session will cover recently approved multiple myeloma treatments from the FDA’s Office of Oncology and Hematology Division of Hematology Products (DHP). FDA speakers include Drs. Barry Miller, Alexandria Schwarsin, Nicole Gormley and Ann Farrell from DHP. More information

Food Advisory Committee Meeting (Dec 7-8)

The Food Advisory Committee will meet to discuss FDA’s policies related to the presence of Listeria monocytogenes in foods. More information

Pulmonary-Allergy Drugs Advisory Committee (Dec 9)

The committee will discuss biologics license application 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd., for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and above, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids.More information

Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and the Risk Management Advisory Committee Meeting (Dec 10)

The committees will discuss the safety of codeine in children 18 years of age and younger. Codeine is used for the treatment of pain in children; however, it is contraindicated for the management of pain after tonsillectomy and/or adenoidectomy. The focus of the meeting will be the risk of serious adverse events, such as respiratory depression and death, including reports in children who are CYP2D6 ultra-rapid metabolizers. The committees will discuss whether the use of codeine in children should be restricted further beyond the current contraindication and whether codeine should be available through the OTC Drug Monograph. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Dec 14)

The committee will discuss the results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). IMPROVE-IT was a clinical trial that studied the effect of ezetimibe/simvastatin compared with simvastatin on the occurrence of cardiovascular events in patients with recent acute coronary syndrome. More information

MDUFA Reauthorization Patient and Consumer Stakeholder Meeting

(Dec 18)

FDA will host a meeting to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During this meeting, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program, and that FDA hold discussions with representatives of patient and consumer groups at least monthly during FDA's negotiations with the regulated industry. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Jan 14)

The committee will hear updates of the research program in the Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. The committee will meet by teleconference. More information

The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (Jan 26)

Objectives of this meeting include discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals (BPs) and other health-related products, and soliciting feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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

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