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Device Panel to Mull Dermal Fillers

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Federal Register notice: FDA announces a 3/23 Medical Devices Advisory Committees General and Plastic Surgery Devices Panel meetin...

Evolved Ayurvedic Discoveries Selling Unapproved CBD Products: FDA

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FDA warns Evolved Ayuverdic Discoveries that its BioCBD+ products are legally considered to be misbranded unapproved new drugs.

False or Misleading Dsuvia Claims in Professional Promotion: OPDP

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The CDER Office of Prescription Drug Promotion warns AcelRx about false or misleading statements about its Dsuvia included in prof...

Novartis Entresto Expanded Indication for Heart Failure

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FDA approves an expanded indication for Novartis Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and ho...

Hahns Kitchen Cabinet Helped Protect FDA: The Hill

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The Hill details how a group of outside scientists came together to help former FDA commissioner Stephen Hahn resist political pre...

FDA Covid-19 Serology Tests Lessons Learned

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CDRHers Jeffrey Shuren and Timothy Stenzel describe lessons learned from the experience with Covid-19 serology tests.

Hard to Reach Conclusions on Lutonix Catheter: FDA

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FDA says it is difficult to draw conclusions on the safety and efficacy of the Lutonix 014 drug-coated balloon PTA catheter.

Pfizer sBLA Approved for Panzyga

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FDA approves a Pfizer supplemental BLA for Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) to treat adu...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Evolved Ayurvedic Discoveries and AcelRx Pharmaceuticals.

FDA OKs Shockwave Coronary Artery Plaque Buster

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FDA approves a Shockwave Medical PMA for its Intravascular Lithotripsy to treat severely calcified coronary artery disease.