“Generic” Biologics Hearing Set By Sen. Hatch; Legislation May Come In 2005
The Senate Judiciary Committee will hold a hearing about "generic" biologics on June 23
You may also be interested in...
FDA's upcoming draft guidance on follow-on biologics will allow use of data that are in the public domain only, Center for Drug Evaluation & Research acting Director Steven Galson, MD, told the Schwab Soundview Washington Research Group health care conference May 5
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