Final FDA flu vaccine guidances
Executive Summary
FDA issues final guidances to outline the regulatory pathways for development and approval of seasonal and pandemic influenza vaccines May 31. Both guidances recommend use of novel adjuvants and cell culture and recombinant manufacturing technologies. Guidelines also allow use of surrogate endpoints such as immune response to support accelerated approval (1"The Pink Sheet" March 13, 2006, p. 26)...
You may also be interested in...
Sixth flu vaccine approved
Accelerated approval of CSL Limited's Afluria for protection against flu virus types A and B in adults marks sixth seasonal influenza vaccine approved by FDA, agency says Sept. 28. CDC estimates a record 132 million vaccine doses will be available for 2007-2008 season (1"The Pink Sheet" Aug. 27, 2007, In Brief)...
Accelerated Approval Gives Wings To Pandemic Flu Vaccine Development
FDA has unveiled a strategy for preventing influenza vaccine shortages and getting a jump on flu pandemics by using surrogate endpoints to accelerate approval of new vaccines
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.