FDA releases draft guidelines for biosimilars

02/9/2012 | Reuters · Bloomberg Businessweek

The FDA has issued draft guidelines for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs. The Generic Pharmaceutical Association is pleased with the FDA's move, saying the guidance is a significant step toward the delivery of "affordable, lifesaving medicines into the hands of doctors and patients."

View Full Article in:

Reuters · Bloomberg Businessweek

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Eastern Zone Sales Director
Regenesis Biomedical
Multiple Locations, SL_Multiple Locations
Director, Compliance - Health Plan Privacy & Security
Kaiser Permanente
Oakland, CA
Regulatory Counsel
Food and Drug Administration
Silver Spring, MD
Pharmacy Care Manager
National Association of Chain Drug Stores
Arlington, VA
Vice President, Commercial Markets
Meridian Health
Neptune, NJ