FDA chief’s pledge signals tougher safety stance Associated Press article where the FDA Chief Talks Tough and talks about the CDRH Head Resigning, CDER Head Accused of Ethical Violations.
Draft FDA Guidance on User Fees
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications A draft guidance has been issued for comment purposes only, see “Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications” issued