BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?
Executive Summary
News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, an update on the Reagan-Udall RWE Accelerator project and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.
You may also be interested in...
US FDA Advisory Committee Members Say Votes Should More Directly Affect Agency Decisions
Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
For US FDA, Modernizing Advisory Committees Includes How Meetings Are Scheduled
Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?
Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions
A survey of advisory committee members finds many believe that an overwhelmingly negative vote should prevent a product approval.