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Searching Content indexed under Healthcare by Carolyn Alenci ordered by Published Date Descending.
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FDA Releases Guidance On REMS Modifications And Revisions
On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS).
United States
23 Aug 2019
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FDA's Guidelines For Petitions Filed Under Section 505(q) Of Food, Drug, And Cosmetic Act
The U.S. Food and Drug Administration (FDA) recently published its guidelines related to citizen petitions and petitions for stays of action under section 505(q) of the federal Food, Drug, and Cosmetic Act (a "Petition").
United States
22 Jun 2011
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