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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...

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Human Drugs

White Paper on Improving Accelerated Approval Path

An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...

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FDA General

Trump Names Erica Schwartz to Head CDC

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

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Animal Drugs

Lilly to Seek FDA Approval for Foundayo in Diabetes

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

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...

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Medical Devices

AdvaMed Recommendations for Class 2 Notification Exemption

AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.

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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 ...