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Device QS Cybersecurity Guidance

[ Price : $8.95]

FDA publishes a guidance on Quality System considerations and the content of premarket submissions relating to medical device cybe...

FDA Rejects Anti-Sweating Gel

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FDA issues Botanix Pharmaceuticals a complete response letter on its NDA for sofpironium bromide gel, indicated for treating prima...

Guide on Animal Antimicrobials Duration of Use

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FDA posts a draft guidance with recommendations on how animal drug sponsors may voluntarily establish a defined duration of use fo...

FDA Pushing EG, DEG Testing

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Reuters says its analysis of FDA regulatory actions shows an agency crackdown on companies that fail to sufficiently test cough sy...

Guilty Plea in Adulterated HIV Meds Case

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The Justice Department says a Florida man pleaded guilty to one count of conspiracy to introduce adulterated and misbranded HIV dr...

Workshop on Dosing Pediatric Study Patients

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Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEP...

FDA Cut Corners to Approve Hetlioz ANDA: Vanda

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Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic fo...

Upcoming CBER Changes Explained

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Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in IN...

Ideaya Bio Gets Fast Track for IDE161

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FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastati...

Ionis Plans NDA for Triglyceride Drug

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Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with...