February to see Flurry of FDA Advisory Committee Meetings
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 |
Methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. | 3-4 February 2014 | |
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 | |
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 | |
The Medicines Company's NDA for Cangrelor Injection | 12 February 2014 | |
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 |
Armstrong Pharmaceuticals' NDA for OTC epinephrine inhalation aerosol (Primatene HFA) | 25 February 2014 | |
Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. | 25-26 February 2014 | |
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 |