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FDA Memo Recommends Califf Order Makenas Withdrawal

[ Price : $8.95]

A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawa...

Intercept Resubmits NDA for Liver Fibrosis Drug

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FDA accepts for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid for use in treating patients with pre-ci...

Medtronic Recalls Extended to More HeartWare Batteries

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Medtronic updates a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12...

Panel to Discuss Opioid Postmarketing Requirement

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FDA plans a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement issued t...

FDA Debars Linda and Mark Godding

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Federal Register notices: FDA issues two orders debarring Linda Godding and Mark Godding for five years from importing or offering...

FDA Lifts Clinical Hold on Pompe Gene Therapy

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FDA lifts a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus ...

ICH Quality Risk Management Guide Adopted by FDA

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The International Conference on Harmonization posts a final guide entitled Quality Risk Management Q9 (R1), which has been adopted...

Conformity Assessment Program Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Accreditation Scheme for Conformity As...

Guide on Developing Dog Heartworm Drugs

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The agency is seeking public comment on the guidance for 60 days.

Surmodics SurVeil PMA Not Approvable: FDA

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FDA says a Surmodics PMA for its SurVeil drug-coated balloon to treat peripheral artery disease is not currently approvable.