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Trump Names Erica Schwartz to Head CDC

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The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy ...

Lilly to Seek FDA Approval for Foundayo in Diabetes

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Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a trea...

Kennedy Hearing Repeatedly Raised FDA Actions

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A House hearing on HHS budget sees lawmakers repeatedly questioning secretary Robert F. Kennedy Jr. on FDA issues, including drug ...

Town Hall Discusses QMSR Basics and Answers Questions

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An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequentl...

Change Labeling for Hormonally Active Contraceptives: Petition

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The Contraceptive Study Group submits a second petition to FDA seeking changes in labeling for hormonally active contraceptives to...

FDA Extends Molgramostim BLA Review for 3 Months

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FDA extends until 11/22 its review of a Savara BLA for molgramostim to treat autoimmune pulmonary alveolar proteinosis.

FDAs No. 2 Brenner May Move to CDC Senior Role

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The Trump Administration looks to move FDA principal deputy commissioner Sarah Brenner to a senior leadership role at the CDC.

FDA Updates Compliance Program for Biologic Drug Manufacturers

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FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug ...

2 CDER Postmarketing MAPPS Out

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CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and...

FDA Panel Meeting to Mull Adding Peptides to Compounding List

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FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs f...