Drug Safety and Risk Management Advisory Committee Meeting
December 12-13, 2012
UPDATED PUBLIC PARTICIPATION INFORMATION
The procedure portion has been updated to an open public hearing from approximately 1:15 p.m. to 1:45 p.m. on December 12 and an open public hearing from approximately 11 a.m. to 11:30 a.m. on December 13.
On December 12, 2012, the committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. On December 13, 2012 the committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing.
Meeting Information
****************************************
Public Meeting on Pharmacy Compounding
December 19, 2012
The FDA will hold a public meeting entitled "Framework for Pharmacy Compounding: State and Federal Roles." At this public meeting, FDA and State representatives will share their perspectives.
Meeting Information
|