GPhA: FDA should revise draft guidelines on biosimilar meetings

06/5/2013 | Bloomberg BNA (free content)

Some revisions are needed for the draft guidance on formal meetings between the FDA and sponsors of biosimilar products, the Generic Pharmaceutical Association said. "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants" must be clarified to guarantee a full understanding of the requirements and expectations of the FDA, the group said. It added the FDA should explain if a request for a first biosimilar advisory meeting can be rejected and give guidance on such situations.

View Full Article in:

Bloomberg BNA (free content)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Consultant
Attest Health Care Advisors
Nationwide, SL_Nationwide
NGS Provider Enrollment Rep
National Government Services - WellPoint
Harrisburg, PA
Consultant
Attest Health Care Advisors
Nationwide, SL_Nationwide
Program Manager II
Tufts Health Plan/Network Health
Medford, MA
Director, Medicare Advantage/Medicare Part D Focus
Avalere Health
Washington, DC