January 28, 2015

ANNOUNCEMENTS

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products FDA's Center for Drug Evaluation and Research compiled a summary of the newly approved novel therapies of 2014.  More information Also see CDER Office of New Drugs Director John Jenkins' FDA Voice Blog on the topic.

FDA takes steps to improve reliability of automated external defibrillators

The FDA issued a final order that will require AED manufacturers to submit premarket approval applications, which undergo a more rigorous review than what was required to market these devices in the past. More information

FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring

FDA allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone. More information

Dr. Robert Califf named FDA Deputy Commissioner for Medical Products and Tobacco

FDA Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the FDA Nominations received on or before March 24, 2015 will be given first consideration for membership on the Science Board to the Food and Drug Administration. More information

General Wellness Policy for Low Risk Devices: Draft Guidance for Industry and FDA Staff

FDA is issuing this draft guidance to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's compliance policy for low risk products that promote a healthy lifestyle (general wellness products). More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first generic esomeprazole FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages one and older.More information

FDA approves new psoriasis drug Cosentyx

FDA approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis. More information

FDA approves Natpara for patients with hypoparathyroidism

FDA approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States. More information

FDA approves a second vaccine to prevent serogroup B meningococcal disease

FDA approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. 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, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

December 2014 Safety Labeling Changes  Pharmacists in the Office of Health and Constituent Affairs reviewed December 2014 labeling changes to inform you of 72 products with safety revisions to prescribing information. More information

Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries

FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern. More information

0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter

Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. 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.

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

Pharmacy Compounding Advisory Committee (Feb 23-24)

Inaugural meeting of the Pharmacy Compounding Advisory Committee to cover various compounding topics. 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

Vaccines and Related Biological Products Advisory Committee (Mar 4)

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season More information

Science Board to the Food and Drug Administration (Mar 4)

The Science Board will be provided with a progress report or a final draft report the Commissioner’s Fellowship Program Evaluation subcommittee and will hear a progress report from Science Moving Forward subcommittee. More information

Dermatologic and Ophthalmic Drugs Advisory Committee (Mar 9)

The committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy. More information

RESOURCES

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

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