Is it possible for FDA regulatory scientists and industry scientists to work together?
1Critical Path Institute, Tucson, Arizona, USA. RWoosley@C-Path.org
Abstract:
The US Food and Drug Administration (FDA) was established as a regulatory agency to protect the public health by ensuring that foods, medications, devices, and many other products are safe, effective, and properly labeled. William Abrams demonstrated that scientists from the pharmaceutical industry and the FDA can work together with integrity and synergy to develop scientific and educational programs, thus paving the way for more recent precompetitive collaborations between the "regulators" and the "regulated."
Related Concept Videos
Drug Regulation
FDA Approved Drugs: Changes to Approved Drugs
Drug Control Governance: Regulatory Bodies and Their Impact
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Bioequivalence studies: Biowaivers
Drug Products: Biologics, Biosimilars and Interchangeables


