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FDA Issues Final Rule And Guidance On Direct-To-Consumer Prescription Drug Advertisements - Broadcasting: Film, TV & Radio

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). ....

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FDA Proposes Standardized Medication Guides

On May 31, FDA proposed a change to standardize and consolidate prescription drug product labels into patient guides with essential medication information on safe use. ....

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FDA Clarifies Approach To Pediatric Drug Development - Life Sciences, Biotechnology & Nanotechnology

On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development. ....

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Withdrawal Of Drug Approval Highlights Risk Of Accelerated Approval Pathway - Food and Drugs Law

On April 5, 2023, the U.S. Food and Drug Administration ("FDA") announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection ("Makena". ....

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