CBER "COMPLETE REVIEW" LETTERS COULD REPLACE "APPROVABLE/NOT APPROVABLE"; INDUSTRY, FDA LIKELY TO ADDRESS "APPROVABLE" DECISIONS IN PDUFA REAUTHORIZATION
FDA's Center for Biologics Evaluation & Research is using "complete review" letters to replace "approvable" or "not approvable" letters for non-user fee applications.
You may also be interested in...
The definition of an efficacy supplement, which covers Rx-to-OTC switch applications, would be written into regulation for the first time under a new proposed rule issued by FDA
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials