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CBER Says Evicel Brochures Make Improper Claims

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CBERs Office of Compliance and Biologics Quality says that promotional materials for Omnix Evicel make inappropriate efficacy, sup...

Industry Backs ICH Drug Guidance, Suggests Changes

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PhRMA, Pfizer, and Merck suggest changes for FDA consideration for an ICH draft guidance on development and manufacture of drug su...

Medicines Co. Resolves Cleviprex Drug Shortage

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FDA says a Medicines Company shortage involving Cleviprex 0.5mg/ml 50 ml vials is now resolved.

Comments Sought on Non-Face-to-Face Tobacco Sales

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Federal Register Notice: Advance notice of proposed rulemaking: FDA requests comments or information on non-face-to-face sale and ...

Comments Sought on Notice of Participation with FDA

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Federal Register Notice: FDA seeks comments on the requirements for filing a notice of participation with FDA.

Guidance on Tobacco Warning Plans

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Federal Register Notice: FDA releases a draft guidance on the submission of warning plans for cigarettes and smokeless tobacco pro...

FDA Clears Fluke Biomedical Patient Monitor Tester

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FDA clears a Fluke Biomedical 510(k) for the ProSim Vital Signs Simulator.

FDA OKs Mylan Generic Allergy Drug

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FDA approves a Mylan Pharmaceuticals ANDA for generic allergy drug promethazine hydrochloride tablets.

Comments Sought on Objections, Hearing Requests

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Federal Register Notice: FDA seeks comments on filing objections and requests for a hearing on a regulation or order.

Comments Sought on MedWatch Form Revisions

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Federal Register Notice: FDA seeks comments on revisions to the MedWatch reporting forms.