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Merck Pneumococcal Vaccine Hits Phase 3 Marks

[ Price : $8.95]

Merck says its investigational V116 21-valent pneumococcal conjugate vaccine hit key immunogenicity and safety endpoints in two Ph...

House Delays FDA Budget Floor Vote

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House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.

Panel to Review BrainStorm ALS Submission

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

FDA Debars Daffin Over Covid Treatments

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

Integrating ORA in Centers Has Risks: Analysis

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

Recall Unapproved Phenobarb Products: Sun

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

Central Admixture FDA-483

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

FDA Hits Medical Device Intended Use Creep

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

Voluntary Consensus Standards Guidance

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

Octapharma NDA for Warfarin Reverser OKd

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