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CBER Labs Answering Stem Cell Questions

[ Price : $8.95]

CBER Cellular and Tissue Therapy branch chief Steve Bauer says that seven of the Centers laboratories are working as a consortium ...

BioDelivery Sciences NDA Planned for Pain Drug

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BioDelivery Sciences says it plans to file an NDA for its pain drug Bema (buprenorphine) before the end of the year after discussi...

Strong Support for FDA Surgical Mesh Reclassification

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Stakeholders representing consumers and patients say they strongly support a proposed FDA order to reclassify some surgical mesh a...

M.D. Science Lab Inspection: CGMP Significant Violations

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FDAs Florida District Office warns M.D. Science Lab about multiple CGMP violations in its receiving, labeling, and distributing of...

Sanofi Launches Authorized Eloxatin Generic

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Sanofi says its Winthrop US subsidiary is launching an authorized generic form of the colorectal cancer treatment Eloxatin.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Atlantic Trading Co., Dean and Jean Mikalunas Farm, Dr. Bronners Magic Soaps, He...

Eisai Sues FDA Over Exclusivity Trigger

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Eisai files suit against FDA for triggering the five-year market exclusivity periods on Belviq and Fycompa allegedly long before r...

FDA Approves Velcade sNDA for Multiple Myeloma Retreatment

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FDA approves a Millennium sNDA for Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma who had previo...

FDA Guidance on GMP Records/Reports

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FDA posts a guidance on Questions and Answers on Current Good Manufacturing Practices - Records and Reports.

Comments Sought on CGMP Dispute Guidance

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Federal Register Notice: FDA seeks comments on a proposed collection of information resulting from the guidance on how to resolve ...