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Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems | Mintz - Health Care Viewpoints


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Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.  ....

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Amendments to the FDA Laws try to Clarify and Improve Systems


Thursday, January 28, 2021
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.  ....

Rare Pediatric Disease Priority Review Voucher Program , Voucher Program , Biden Harris Administration , Branch On , Trump Administration , Rare Disease Priority Review Voucher Program , Drug Administration , Authority To Require Updating Generic Drug , Public Health Service , Government Accountability Office , Executive Branch , President Biden , Coronavirus Response , Coronavirus Aid , Economic Security Act , Federal Food , Cosmetic Act , Public Health Service Act , Require Updating Generic Drug , Making Objective Drug Evidence Revisions , Labeling Act , Biologic Marketing Exclusivity , Orphan Drug Act , Prescription Drug User Fee Act , Purple Book Database , Purple Book ,