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Federal Register

Panel to Review BrainStorm ALS Submission

Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainStorm Therapeutics sup...

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Federal Register

FDA Debars Daffin Over Covid Treatments

Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an approved or pending drug ...

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FDA General

Integrating ORA in Centers Has Risks: Analysis

Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.

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Human Drugs

Recall Unapproved Phenobarb Products: Sun

Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dangers of those product...

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Human Drugs

Central Admixture FDA-483

FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.

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Medical Devices

FDA Hits Medical Device Intended Use Creep

Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is promoted for uses b...

Human Drugs

Voluntary Consensus Standards Guidance

FDA issues a final guidance describing CDERs program for the recognition of voluntary consensus standards related to drug quality.

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Human Drugs

Octapharma NDA for Warfarin Reverser OKd

FDA approves an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induce...

Medical Devices

Abbott Recalls Amplatzer Delivery Sheath

Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients undergoing procedures.

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Human Drugs

Defender Pharma NDA for Scopolamine Gel

Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vomiting in adults.