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OTC Drug Dispute Resolution Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the formal dispute resolution and administrative hearing process for over-the-counter monograph ...

Medical Imaging Drugs Panel Renewal

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Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years bey...

Arrow Recalls Peripheral Catheter System

[ Price : $8.95]

Arrow International recalls its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separa...

Indian Drug Companies Sharing Compliance Info

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A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an ...

FDA Accelerated Approval for Duchenne Gene Therapy

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FDA grants Sarepta Therapeutics an accelerated approval for its BLA for Elevidys, the first gene therapy for treating pediatric pa...

FDA Posts 483 of PQ Drug Outsourcing Facility

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A 10/2022 inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL leads to a just-posted seven-item Form FDA-483 th...

FDA Clears At-home Pulse Baby Monitor

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FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.

FDA OKs New Colonoscopy Prep

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FDA approves Sebelas Suflave colonoscopy prep that reportedly tastes like a sports drink and thus is easier to use.

Suggestions for Pharmacogenomic Data

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Five stakeholders express appreciation for a revised FDA draft guidance on pharmacogenomic data submissions and suggest changes to...

FDA OKs Jardiance/Synjardy for Pediatric Diabetes

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FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatment...