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FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
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Why Are Post-Approval Pregnancy Studies Post-Marketing Requirements Rather Than Post-Marketing Commitments? - Food and Drugs Law

New Year's is often associated with baby New Year and with resolutions, which in a convoluted way got us thinking about post-approval pregnancy studies. ....

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Annual Status Report Information and Other Submissions for Postmarketi

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry ....

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FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations | BakerHostetler

In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on. ....

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