FDA Schedules Follow-On Biologics Workshop For September
This article was originally published in The Pink Sheet Daily
Executive Summary
The meeting on “Scientific Considerations Related to Developing Follow-on Protein Products” will take place Sept. 14 and 15. FDA is seeking input on creating a scientific framework for a follow-on biologics approval process.
You may also be interested in...
FDA Makes It Official: Action On Human Growth Hormone Will Wait
Sandoz presents FDA's deferral of a decision on Omnitrope application as a tentative approval. The agency has completed its review of the recombinant human growth hormone product and did not identify any deficiencies, Sandoz says.
FDA Makes It Official: Action On Human Growth Hormone Will Wait
Sandoz presents FDA's deferral of a decision on Omnitrope application as a tentative approval. The agency has completed its review of the recombinant human growth hormone product and did not identify any deficiencies, Sandoz says.
FDA Follow-On Biologics Public Meeting Slated For Early 2005
Projected timing of the meeting suggests that release of a draft guidance will not occur until at least a year after FDA’s original projected timeframe of spring 2004.