February 25, 2015

ANNOUNCEMENTS

Vacancy Announcement for Deputy Director, Office of Generic Drugs

This position is located in the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The incumbent will serve as the Deputy Director of the OGD and participate fully in the day-to-day operations of the Office. In the absence of the Director, s/he acts with full authority in carrying out the variety of scientific, technical and administrative duties required of that position. More information

Shedding some light on FDA’s review of sunscreen ingredients and the Sunscreen Innovation Act

On November 26, 2014, Congress enacted the Sunscreen Innovation Act (SIA) that provides a new process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. FDA is taking initial action on the last two pending ingredients, ecamsule and enzacamene. We tentatively determined, as we had with the other six ingredients, that we need more data to decide if these ingredients are, in fact, GRASE for use in OTC sunscreen products. Information about the SIA and our recent actions under the law are available on our new web page for this topic. At this time there is not enough generally available data to determine whether any of the ingredients under review meet FDA’s safety and effectiveness standards. More information

Recent Progress on Demographic Information and Clinical Trials

Section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to look at these questions on a broader scale: to investigate how well demographic subgroups (sex, age, race and ethnicity) are included in clinical trials; whether they are analyzed for safety and effectiveness by these subgroups; and to improve on making the resulting information available to the public. After systematically reviewing 72 medical product applications, FDA published a report, in August 2013, which concluded that FDA has been doing a good job, but we acknowledged we could do better. In August of last year we came up with a plan to improve our performance. The Action Plan includes 27 action items. The agency is making significant progress on the implementation of the FDASIA 907 Action Plan. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

FDA issues new draft documents related to compounding of human drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states. The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA. More information

Environmental Protection Agency and Food and Drug Administration Advice About Eating Fish: Closure of the Public Comment Period

On June 11, 2014, the Food and Drug Administration (FDA), in coordination with the U.S. Environmental Protection Agency (EPA), (the Agencies), released for public comment draft fish consumption advice entitled “Fish: What Pregnant Women and Parents Should Know.” The draft advice would update the Agencies' consumption advice and recommend that women who are pregnant (or might become pregnant) or nursing and anyone who prepares food for young children eat certain amounts and types of fish in order to improve health and developmental outcomes while minimizing risk from methylmercury in fish. The comment period will close on March 26, 2015. More information

National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web Site Location and Request for Comments

FDA is announcing the availability of the report and Web site location where the Agency has posted the report entitled “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” developed by the National Medical Device Postmarket Surveillance System Planning Board. In addition, FDA has established a docket where stakeholders may provide comments. Submit either electronic or written comments by April 27, 2015. More information

FDA is opening a docket to obtain information and comments on specific areas of public health concern for racial/ethnic demographic subgroup populations, focusing on certain disease areas where significant outcome differences may be anticipated. The Agency is seeking public input on identifying areas that can be addressed through regulatory science research. Submit either electronic or written comments or information by April 27, 2015. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves Farydak for treatment of multiple myeloma

FDA approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. More information

FDA approves closure system to permanently treat varicose veins

FDA approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. More information

FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome

FDA authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. More information

FDA approves Lenvima for a type of thyroid cancer

FDA granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). More information

FDA permits marketing of fecal incontinence device for women

FDA allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women. Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery. 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.

Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility

Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. More information

Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning

Patients may be exposed to serious infections. More information

January 2015 Drug Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed January 2015 labeling changes to inform you of 25 products with revisions to prescribing information. 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.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (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

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 Meeting (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 Meeting (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

Arthritis Advisory Committee Meeting (Mar 17)

The committee will discuss biologics license application (BLA) 125544 for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. More information

Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Mar 18)

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium. More information

Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Mar 19)

The committees will discuss supplemental new drug application 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended. More information

Pediatric Ethics Subcommittee of the Pediatric Advisory Committee Meeting

(Mar 23)

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. More information

Public Meeting: Stakeholder Input on the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (Mar 25)

The purpose of this public meeting is for FDA to obtain input from patient groups, consumer groups, regulated industry, academia and other interested parties on any recommendations or information relevant to the report to Congress that FDA is required to submit to Congress as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The topics to be discussed at the meeting will include, but not be limited to, pediatric labeling changes, waivers and deferrals, Written Requests, pediatric study plans, programmatic activities with the NIH Written Request referral process, activities concerning neonates, pediatric cancers and rare diseases, and transparency. More information

Public Workshop: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (Mar 30-31)

FDA's Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).” The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease. 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