Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
|
Topic |
Advisory Committee |
Date |
|
Risk of serious neurologic adverse reactions associated with epidural steroid injections administered to reduce inflammation for pain management; committee also will consider efficacy and overall risk/benefit balance of injecting steroids in the epidural space to treat pain |
Anesthetic and Analgesic Drug Products |
Nov. 24-25 |
|
Issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options |
Anti-Infective Drugs |
Dec. 4 |
|
Cerexa’s ceftazidime/avibactam for complicated intra-abdominal infections; complicated urinary tract infections, including acute pyelonephritis; and a limited-use indication for aerobic gram-negative infections with limited treatment options |
Anti-Infective Drugs |
Dec. 5 |
|
Gauge investigator interest in potential pediatric development plans for Synta’s ganetespib, Nektar’s etirinotecan and Roche’s RO5503781; discuss issues concerning diseases to be studied, patient populations to be included and possible study designs for pediatric development; assist with formulation of written requests for pediatric studies, if appropriate |
Oncologic Drugs (Pediatric Oncology Subcommittee) |
Dec. 11 |
|
Closed meeting for discussion of whether FDA should permit further clinical development of an existing investigational drug product, which will include the review of trade secret and/or confidential information |
Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management |
Dec. 18 |
|
Astellas Pharma Global Development’s isavuconazonium sulfate capsules and isavuconazonium sulfate for injection for treatment of invasive aspergillosis and mucormycosis |
Anti-Infective Drugs |
Jan. 22 |