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FDA General

Kennedy Hearing Repeatedly Raised FDA Actions

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

Human Drugs

FDA Satellite Labs Block Illegal Drugs: Batson

FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilities to stop illegal an...

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Federal Register

Phillips Ventilator Correction is Class 1 Recall

FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices witho...

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Human Drugs

FDA Seeks Expanded Use of Testosterone Therapies

FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be approved to treat lo...

Animal Drugs

2 CDER Postmarketing MAPPS Out

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

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Human Drugs

FDA Panel Meeting to Mull Adding Peptides to Compounding List

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

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Medical Devices

Town Hall Discusses QMSR Basics and Answers Questions

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

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Human Drugs

Change Labeling for Hormonally Active Contraceptives: Petition

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

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Human Drugs

FDA Extends Molgramostim BLA Review for 3 Months

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

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FDA General

FDAs No. 2 Brenner May Move to CDC Senior Role

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