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Whistleblower Flags OCI Director to Grassley

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Sen. Charles Grassley says a whistleblower has told him of several on-the-job indiscretions committed by FDA Office of Criminal In...

FDA Warns About 'Chelation' OTC Products

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FDA advises consumers to avoid chelation products that are marketed over-the-counter to prevent or treat diseases.

ReGen Scaffold Should Not Have Been Approved: FDA

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After failing to give itself explicit authority to rescind such decisions, FDA now says a review has shown that ReGen Biologics Me...

Company Behind Contaminated Heparin API Faces New FDA Probe

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FDA says the company behind a contaminated active pharmaceutical ingredient related to Baxter's heparin scandal in 2008 is the sub...

FDA Approves REMS for Gabitril

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Cephalon gains FDA approval for a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication Gabitril.

FDA to Target CEOs Personally in Off-label Promotion Suits

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FDA deputy chief counsel for litigation Eric Blumberg tells an industry conference that the agency is looking at flagrant off-labe...

FDA OKs Talecris Gamunex-C for Primary Immunodeficiency

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FDA approves Talecris Biotherapeutics Gamunex-C for subcutaneous administration to treat primary immunodeficiency.

FDA OKs Pharmacia & Upjohn sNADA for Dairy Cows

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Federal Register Final rule: FDA approves a Pharmacia & Upjohn supplemental NADA for using progesterone intravaginal inserts and d...

Guidance on INDs with Live Biotherapeutic Products

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Federal Register Notice: FDA releases a draft guidance on early clinical trials with live biotherapeutic products.

Guidance on Determining if a Study Requires an IND

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Federal Register Notice: FDA releases a draft guidance, Investigational New Drug Applications (INDs) Determining Whether Human Re...