RAPS

Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
UPI

To promote drug safety, FDA to replace animal testing with AI-based experiments, other methods

April 10 (UPI) --The U.S. Food and Drug Administration is replacing animal testing with human-relevant methods, including artificial intelligence, when developing monoclonal antibody therapies and ...
Regulatory Affairs Professionals Society

FDA finalizes two guidances for industry on establishing bioequivalence

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...