Tag Archives: postmarketing studies

Competing bills propose amendments to FDA’s accelerated approval program

The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval Program. The committee’s Democratic chairman, Frank Pallone, Jr. (D-NJ) and Republican ranking member, Cathy McMorris Rodgers (R-WA) have proposed competing bills that were featured prominently in the Health Subcommittee’s legislative hearing on March 17, … Continue Reading

Drugs Approved on the Basis of Surrogate Endpoints

This post was written by Paul Sheives. FDA is authorized to approve applications based on clinical trials that demonstrate a new drug’s impact on a “surrogate endpoint,” or laboratory measure or physical sign used as a substitute for a clinical endpoint. When FDA approves a drug based on a surrogate endpoint under an accelerated approval … Continue Reading