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Watson Asks Bioequivalence Limits on Generic Androderm

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Watson asks FDA not to approve any ANDA for generic Androderm that doesnt include a study of time to reach maximum testosterone fo...

FDA Posts Safety Labeling Changes to 37 Products

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FDA approves safety labeling changes for 37 drugs, including anaphylactic reactions for 10 neuromuscular blockers.

FDA Funds IoM Review on Pediatric Studies

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FDA funds a new Institute of Medicine review on pediatric drug and biologic studies requested under the Best Pharmaceuticals for C...

Penumbra Recalls Reperfusion Catheter 032

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Penumbra recalls 77 reperfusion catheter 032s due to a manufacturing error that endangers patients experiencing stroke.

FDA OKs Agri Labs sANADA for Dairy Cows

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Federal Register Final rule: FDA approves an Agri Laboratories sANADA for use of flunixin meglumine solution for control of pyrexi...

FDA OKs Huvepharma ANADA for Bacterial Diseases

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Federal Register Final rule: FDA approves a Huvepharma ANADA for using tylosin tartrate in drinking water to control various bacte...

FDA Approves 2nd Collagenase Manufacturing Facility

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FDA approves a second production facility for making Healthpoint's Collagenase Santyl Ointment, a biologic enzymatic debriding age...

FDA Seeks Participants in Biosimilar User Fee Program

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Federal Register Notice: FDA asks that public stakeholders notify the agency if they intend to participate in consultation meeting...

FDA Grants Opana Bioequivalence Limit

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FDA grants one part and denies other parts of an Endo Citizen Petition on bioequivalence of generic forms of Opana ER.

QS Problems Found at Steris Isomedix Facility

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FDAs Dallas District Office warns Steris Isomedix about Quality System violations in its contract sterilization of medical devices...