Cole Werble
It’s not a written, formal policy, but there is a new rule for sponsors preparing new drug applications for review by the Food & Drug Administration: me-too drugs for symptomatic relief of a medical condition are
Nervous Times for NDA Sponsors: The New Reality of FDA Drug Reviews
FDA is adopting a broad range of procedural changes in response to suggestions from outside critics to address drug safety issues. The most significant change, however, may be just a new state of mind.