Drug Safety Legislation To Be Introduced April 27
This article was originally published in The Pink Sheet Daily
Executive Summary
Sens. Grassley and Dodd are proposing the creation of a “Center for Post-market Drug Evaluation & Research” that would be independent from FDA’s existing drug safety infrastructure. Proposals for an independent drug safety office have elicited mixed reactions from the agency.
You may also be interested in...
Drug Safety Board Is Biased By Connection To CDER, Sen. Grassley Says
Grassley is asking FDA to outline the specific steps that will be taken to ensure the independence of the committee. A letter to FDA Acting Commissioner Crawford was released the same day the Institute of Medicine convened its meeting to study FDA’s drug safety review practices.
Drug Safety Board Is Biased By Connection To CDER, Sen. Grassley Says
Grassley is asking FDA to outline the specific steps that will be taken to ensure the independence of the committee. A letter to FDA Acting Commissioner Crawford was released the same day the Institute of Medicine convened its meeting to study FDA’s drug safety review practices.
Drug Safety Act Expands Withdrawal Authority; Final Decision Rests With Commissioner
The proposed FDA Safety Act would enable the Center for Postmarket Drug Evaluation & Research to call for a drug's withdrawal, with final authority retained by the FDA commissioner