February to see Flurry of FDA Advisory Committee Meetings

Posted 08 January 2014 By Alexander Gaffney, RAC

Even by the usual standards of the US Food and Drug Administration (FDA), it has been an unusually busy week for announcing advisory committee meetings.

The committees, which offer regulators non-binding but influential advice that is generally followed, are often called upon to either assess new products or niche problems requiring specialized or public input.

This week has already seen a flurry of announcements for upcoming advisory committee meetings, with no fewer than nine meetings scheduled since 31 December 2013. A listing of those meetings and brief summaries of their respective topics may be found below, as well as two additional meetings scheduled the week prior.

Meetings

Topic(s)

Date

Risk Communications Advisory Committee

Methods for identifying the impact and increasing the reach of communications on topics of interest to consumers.

3-4 February 2014

Science Board to the Food and Drug Administration

Discussion of the draft final report from FDA's Global Health subcommittee; CDRH presentation of report; CBER update on post-marketing safety review activities

5 February 2014

Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Discussion of data and analyses about the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling

10-11 February 2014

Cardiovascular and Renal Drugs Advisory Committee

The Medicines Company's NDA for Cangrelor Injection

12 February 2014

Cardiovascular and Renal Drugs Advisory Committee

Novartis' BLA for Serelaxin Injection

13 February 2014

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

The premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company.

14 February 2014

Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

Inspire Medical Systems' PMA for the Inspire II Upper Airway Stimulator

20 February 2014

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

The regulatory classification of iontophoresis devices

21 February 2014

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee

Armstrong Pharmaceuticals' NDA for OTC epinephrine inhalation aerosol (Primatene HFA)

25 February 2014

Cellular, Tissue, and Gene Therapies Advisory Committee

Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. 

25-26 February 2014

Nonprescription Drugs Advisory Committee

Whether OTC bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing) should be removed from the monograph. 

26 February 2014


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