The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to ...
July 2025 brought a flicker of hope for people with serious health needs: Congress exempted drugs with multiple orphan indications from the Inflation Reduction Act (IRA)’s Medicare Drug Price ...
Post-approval research on existing medicines has improved patient outcomes and addressed unmet medical needs. In oncology, post-approval improvements to drugs reflect indications for additional cancer ...
Clinical development programs for new drugs include an array of research conducted both before and after a drug’s initial approval by the Food and Drug Administration (FDA). Post-approval clinical ...
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