PhRMA, BIO Question Impact Of Exploratory INDs On Patent Restoration
Industry stakeholders are questioning the potential impact of exploratory investigational new drug applications on Waxman/Hatch patent restoration provisions
You may also be interested in...
FDA should expand its "Exploratory IND" guidance to make it easier for manufacturers to do pilot studies involving radioactive tracers, Merck Division of Imaging Senior Director David Mozley told a May 5 meeting on "Critical Path" opportunities cosponsored by FDA, the Biotechnology Industry Organization and the Drug Information Association in Bethesda, Md
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