The Advisory Committee calendar put up by FDA is very useful, but lists the upcoming meetings chronologically by date and by their named committee. I thought it might be helpful every so often to provide an overview of upcoming AdComm meetings by topic instead so that one can readily discern where there is likely to be news. So here is my first effort, notable perhaps for the fact that there is little action related to new drug approval.
ASSISTED REPRODUCTION
- Oocyte Modification – The Cellular, Tissue and Gene Therapies Advisory Committee will meet to discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease on February 25-26.
ASTHMA
- Inhaler Replacement – There will be a joint meeting of the Pulmonary Drugs Advisory Committee with the Non-Prescription Drugs Advisory Committee to discuss use of an epinephrine inhaler for OTC use that would replace a discontinued version – on February 25.
- OTC Bronchodilators – There will be a meeting of the Non Prescription Drugs Advisory Committee to consider whether OTC bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma should be removed from the monograph on February 26.
CARDIOVASCULAR
- NSAIDS and CV Risk – Meeting of the Arthritis Drugs AdComm with the Risk Management Advisory Committee, February 10-11;
- NDA for cangrelor Injection – Submitted by The Medicines Company – Meeting of the Cardiovascular and Renal Drugs Advisory Committee for the proposed indication of reduction of thrombotic cardiovascular events, including stent thrombosis, in patients with coronary artery disease undergoing PCI, February 12;
- BLA for seralaxin Injection – Submitted by Novartis – Meeting of the Cardiovascular and Renal Drugs Advisory Committee for the proposed indication to improve symptoms of acute heart failure, February 13.
HPV
- New Indication for Test – The Microbiology Devices Panel will meet to discuss the premarket approval application for a new indication as a first line primary cervical screening test for the cobas Human Papillomavirus (HPV) Test, sponsored by Roche Molecular Systems, on March 12.
INFLUENZA
- Flu Strains – The Vaccines and Related Biological Products Committee will meet to hear an overview of a research program in the Laborary of Respiratory Viral Diseases, CBER and then will discuss and make recommendations on the selection of strains to be included in the flu virus vaccine for the 2014-2015 season on February 28.
OPHTHALMOLOGY
- PreMarket Application for new lens – Meeting of Ophthalmic Devises Panel to discuss application from Starr Surgical Company for Visian Toric Implantable Collamer Lens (TICL) for new lens for the treatment of addressing myopic astigmatism in adults 21-45, February 14.
REGULATORY/POLICY
- Regulatory Considerations – The Orthopaedic and Rehabilitation Devices Panel will meet to discuss the regulatory classification of iontophoresis devices on February 21.
SLEEP APNEA
- PreMarket Application for new device – Meeting of the Anesthesiology and Respiratory Therapy Devices Panel to consider application for Inspire Medical Systems’ Inspire II Upper Airway Stimulator to be a permanently implanted device to treat moderate to severe sleep apnea in patients not effectively being managed with continuous positive airway pressure devices, February 20.
In addition to this, I have begun a data base on Advisory Committees held since 2009 that will profile a number of characteristics, including outcomes. More on that later.
