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FDA Rejects Teva/MedinCell Risperidone NDA

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FDA issues Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-r...

NCTR Science Advisory Board Panel Meeting

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Federal Register notice: FDA announces a 5/18-19 meeting of the Science Advisory Board to the National Center for Toxicological Re...

Center for Rare Neurological Diseases Warned on 2 Trials

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FDA warns the Norcross, GA-based Center for Rare Neurological Diseases about human subject protection violations in its conduct of...

Published Literature Used for Animal Drugs Guide

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Federal Register notice: FDA makes available a draft guidance for industry #106 entitled The Use of Published Literature in Suppor...

FDA Corrects ANDA Withdrawal Notice

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Federal Register notice: FDA corrects a 2/28 notice announcing the withdrawal of approval of five ANDAs from multiple applicants.

CGMP Violations at Vi-Jon Facility

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FDA warns St. Louis, MO-based Vi-Jon about CGMP violations in its production of finished drugs.

12 Warning Letters Sent to Skin Bleaching Marketers

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Based on adverse events received, FDA sends Warning Letters to 12 companies for selling unapproved over-the-counter products inten...

Drug Companies Must Assume Messaging Risks: Attorneys

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Two Arnall Golden Gregory attorneys recommend that drug companies keep all FDA promotion regulations in mind when they craft consu...

Regenerative Stem Cell Institute Unapproved Cell Products

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FDA says the Elgin-IL-based Regenerative Stem Cell Institute is marketing cellular products without an approved BLA or IND.

High Bar for Vaccine Liability Claims

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Three Morrison Foerster attorneys say a recent Connecticut federal court decision in a case involving Mercks Gardasil demonstrates...