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White Paper on Improving Accelerated Approval Path

[ Price : $8.95]

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

AdvaMed Recommendations for Class 2 Notification Exemption

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

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 ...

FDA Satellite Labs Block Illegal Drugs: Batson

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FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilitie...

Phillips Ventilator Correction is Class 1 Recall

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

FDA Seeks Expanded Use of Testosterone Therapies

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

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...