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FDA Streamlined Compliance Policy for Certain Respirators

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FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators ...

Opna Bio Wins FDA Fast Track for Multiple Myeloma Drug

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FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with r...

Collins Presses for Faster Generic Competition at Hearing

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U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on...

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 ...

White Paper on Improving Accelerated Approval Path

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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...