In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often. Today is every so often. It is just a different way of viewing the very useful calendar put up by FDA. The February posting was notable because there were so few new product considerations while April saw a bump up in that regard. This time around there are NDAs, BLAs and PMAs.
- Combination Drugs – On September 10, the Cardiovascular and Renal Drugs Advisory Committee will meet to discuss the potential clinical utility of fixed-combination prescription drugs that are composed of an an anti-hypertensive with a statin and aspirin to reduce cardiovascular events and death in patients with a CV history, focusing in particular whether such a product would have a benefit and various other questions related to the possible use.
- NDA Approval Consideration – On August 14, the Pulmonary-Allergy Drugs Advisory Committeee will meet to consider an NDA submitted by Boehringer Ingleheim for tiotripium bromide inhalation sprace for the proposed indication of long-term, once-daily maintenance treatment of bronchospasms associated with COPD.
- Regulatory Classification - On July 31, the Gasteroenterology and Urology Devices Panel of the Medical Devices AdComm will meet to make recommendations regarding the classification of a number of devices considered pre-amendments devices since they were in commercial distribution prior to May 28, 1976 when the Medical Devices Amendements became effective. FDA is seeking input on the safety and effectiveness of the devices and the regulatory classification. The devices include Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electical Sperm Collection, Erectile Dysfunction Devices and Alloplastic Spermatoceles.
- BLA Approval Consideration – The Endocrinologic and Metabolic Drugs Products Advisory Committee will meet on September 12 to consider a BLA from NPS Pharmaceteuticals for NATPARA (Recombinant Human Parathyroid Hormone) for the proposed indication of replacement for endogenous parathyroid hormone for the long-term treatment of hypoparathyroidism.
- BLA Approval Consideration – This week on the morning of July 31 the Blood Products Advisory Committee will meet to discuss the biologics license application of Baxter Healthcare for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune disorders. During an afternoon session, the committee will be meeting in open session to discuss reentry of blood donors who had been deferred based on Chagas disease test results.
- PMA Consideration - Also this week on July 30, the Gasteroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will meet to discuss the premarket approval of the Ablaterm Integrated Imaging device sponsored by EDAP Technomed, Inc. for the primary treatment of prostate cancer in subjects with low-risk, localized prostate cancer.
- NDA Approval Consideration – The Dermatologic and Ophthalmic Drugs Advisory Committee will meet to consider the BLA submitted by Novartis for a monoclonal antibody that is being proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic or phototherapy.
- Adverse Event Discussion – There will be a joint meeting of the Drug Safety and Risk Management and the Psychopharmacologic Drugs Advisory Committee to discuss the risk of serious neuropsychiatric adverse events with CHANTIX tablets as well as options for addressing risk.
- PMA Consideration - On August 1, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet to consider the pre-market application for Cohera Medical’s TissueGlu Surgical Adhesive device for the proposed indication for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.
TESTOSTERONE REPLACEMENT THERAPY
- Safety Issues – There will be a joint meeting of the Bone, Reproductive and Urologic Drugs AdComm with the Drug Safety and Risk Management AdComm on September 17 to discuss the appropriate indicated population and potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- NDA Approval Consideration - On the following day, September 18, there will again be a joint meeting of the two committees to consider an NDA submitted by Clarus Therapeutics for a investigative oral testosterone replacement therapy treatment.