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
MGR POST MARKET STUDIES - 14000001LK
Abbott
Santa Ana, CA
Regulatory Analyst
Delta Dental
Alpharetta, GA
Eastern Zone Sales Director
Regenesis Biomedical
Multiple Locations, SL_Multiple Locations
Senior Financial Analyst - Growing Manager Care Health Org
Fallon Community Health Plan
Worcester, MA
Associate Director, Regulatory Affairs - Promotional Review
Novo Nordisk
Princeton, NJ