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11 Observations on Hybrid Pharma FDA-483

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FDA releases the form FDA-483 with 11 observations from an inspection at the Deerfield, FL-based Hybrid Pharma outsourcing facilit...

New HCP Drug Interaction Web Site

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The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involv...

Dupixent Wins FDA Expanded Indication

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FDA approves an expanded indication for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) for treating pediatric patients...

AI-Assisted Chest X-ray Cleared

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FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triag...

Details on 22 Covid EUAs from 2023

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Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices a...

Guide on GMPs for Veterinary APIs

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Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingre...

Vitacell Biologics Illegally Selling Cellular Products: FDA

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CBER says Lewisburg, TN-based Vitacell Biologics is illegally marketing cellular and exosome products.

STAQ Pharma of Ohio FDA-483

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FDA releases the form FDA-483 with two inspection observations issued to Columbus, OH-based STAQ Pharma of Ohio.

22 T-Cell Cancers After CAR-T Treatment: CBER

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CBER executives say FDA is aware of a relatively small number of cases in which people treated with CAR-T products developed secon...

Final ANDA Label Revision Guidance

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FDA issues a finalized guidance on updating ANDA labels following revisions to the reference-listed drug label.