The next phase of the US Food and Drug Administration’s roll-out of a new structure for its drug review operations will take place in mid-January.
US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."