Designation further supports (Z)-Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pediatric Disease Designation ... .
Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agency’s political appointees and senior leaders.
THE Food and Drug Administration (FDA) has confirmed receiving 25 reports related to the voluntary recall of certain batches of Nan Optipro and Nankid Optipro infant formula products ... Concerns may also be reported via ereport@fda.gov.ph.
The initiative by FDACommissionerMarty Makary promises ultra-fast reviews for drugs that align with “U.S ... But FDA staffers say the push for faster approvals is contributing to a climate of anxiety, ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times ... .