FDA Follow-On Biologics Public Meeting Slated For Early 2005
This article was originally published in The Pink Sheet Daily
Executive Summary
Projected timing of the meeting suggests that release of a draft guidance will not occur until at least a year after FDA’s original projected timeframe of spring 2004.
You may also be interested in...
Follow-On Biologics Should Be Handled Through Legislation – Senate Staffer
The Senate Health Committee will evaluate the science and law of follow-on biologics, Health Policy Staff Director Northrup says. Although the committee's work is in the early stages, congressional action, not a "regulatory or administrative fiat" from FDA, is the next step.
Follow-On Biologics Should Be Handled Through Legislation – Senate Staffer
The Senate Health Committee will evaluate the science and law of follow-on biologics, Health Policy Staff Director Northrup says. Although the committee's work is in the early stages, congressional action, not a "regulatory or administrative fiat" from FDA, is the next step.
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.