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FDA Revokes Sublocade Orphan Drug Designation

[ Price : $8.95]

FDA revokes its orphan drug designation for Indiviors Sublocade because it was improperly granted.

Baraclude Label Updated with Safety Study Results

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FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.

EIP Pharma Fast Track for Dementia Drug

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FDA grants EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies.

Comments Sought on Post-market Surveillance Practices

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Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance.

Senator Probing Drug Shortages, Prices

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Michigan Sen. Gary Peters say he intends to investigate solutions to increasing drug prices and drug shortages.

ASCA Pilot Should Help Device Premarket Review: CDRH

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CDRHer Stacy Cho outlines elements in a draft guidance to create an Accreditation Scheme for Community Assessment pilot program.

FDA Approves Fluzone High-Dose Quadrivalent

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FDA approves a Sanofi supplemental BLA for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age an...

FDA Alliance Advocates for Increased FDA Funding

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The Alliance for a Stronger FDA advocates for increased FDA funding in fiscal year 2020 because growing responsibilities require a...

Zimmer ROSA Brain System Recall Class 1

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FDA says the Zimmer Biomet recall of ROSA 3.0 robotic surgery systems is Class 1.

Tripartite Meeting Looks at Antibacterial Regulation

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Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on...