jueves, 9 de febrero de 2017

FDA Updates for Health Professionals | UPCOMING MEETINGS

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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.

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 23)

FDA announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel® Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures. More information

FDA and USP Workshop on Standards for Pharmaceutical Products - “Critical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future” (Feb 27 - 28)

A discussion of how the quality and variability of excipients currently impact medicines and how they are expected to impact new technologies such as Continuous Manufacturing and Novel Delivery systems. More information

Pediatric Advisory Committee Meeting (Mar 6 - 7)

The committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for NITROPRESS (sodium nitroprusside), KUVAN (sapropterin dihydrochloride) and TRUVADA (emtricitabine/tenofovir disoproxil fumarate). The FDA will provide the analysis of a possible safety signal regarding the use of the drug product EXJADE (deferasirox) in children with fever and dehydration that was discussed at the September 2015 PAC meeting. The PAC will also discuss the role of pharmacogenomics in pediatric product development. The committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for: EPICEL, IMPELLA RP SYSTEM, LIPOSORBER LA-15 SYSTEM, MEDTRONIC ACTIVA DYSTONIA THERAPY. The Committee will also discuss pediatric-focused safety reviews for NOVOEIGHT  and RIXUBIS Coagulation Factor IX. More information

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (Mar 13 - 14)

The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling. The committees will be asked to discuss pre- and post-marketing data about the abuse of OPANA ER, and the overall risk-benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products. More information

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (Mar 15)

The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar. More information

Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee (Mar 17)

The committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products.  Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products. More information

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