The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...
The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
MedPage Today on MSN
FDA Proposes New Approval Pathway for Rare Disease Gene Therapy
Will consider data that includes "the experience of individuals," FDA commissioner says ...
The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...
The Trump administration’s injection of political priorities into the agency, which has long been shielded from such meddling, has opened new avenues for lobbying.
Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...
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