Recent And Upcoming FDA Advisory Committees
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
|
Topic |
Advisory Committee |
Date |
Details |
|
Selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season |
Vaccines and Related Biological Products |
Oct. 13 (teleconference) |
(Also see "Sanofi-Pasteur's Southern Strategy Gets Its Own FDA Advisory Committee" - Pink Sheet, 11 Oct, 2016.) |
|
Serenity Pharmaceuticals' desmopressin 0.75 mcg/0.1 ml and 1.5 mcg/0.1 ml nasal spray for treatment of adult-onset nocturia |
Bone, Reproductive and Urologic Drugs |
Oct. 19 |
|
|
Updates on research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products in CBER's Office of Vaccines Research and Review (open session); intramural research program reports and recommendations on personnel staffing decisions (closed session) |
Allergenic Products |
Oct. 27 (teleconference) |
|
|
Five bulk drug substances nominated for inclusion under Section 503A of the FD&C Act; drug products that employ transdermal and topical delivery systems that were nominated for the “difficult to compound” list |
Pharmacy Compounding |
Nov. 3 |
|
|
Cempra Pharmaceuticals' solithromycin capsules and injection for treatment of community-acquired bacterial pneumonia |
Antimicrobial Drugs |
Nov. 4 |
(Also see "Cempra's Solithromycin On Track To Enter Generic, But Resistant, CABP Market" - Pink Sheet, 29 Aug, 2016.) |
|
Recommendations on FDA’s draft Strategic Plan for Risk Communication and Health Literacy; presentations on some of FDA’s external communications and how these relate to the draft strategic plan |
Risk Communication |
Nov. 7 |
|
|
Appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis |
Bone, Reproductive and Urologic Drugs |
Dec. 6 |