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Compounding Drug HORV Alert

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FDA issues a compounding drug alert for hemorrhagic occlusive retinal vasculitis in patients receiving injection of a compounded v...

FDA Clears Solta Skin Smoothing Device

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FDA clears a Solta Medical 510(k) for its Thermage FLX System to smooth skin on the face, eyes and body.

FDA Approves Mylans Generic Copaxone Copies

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FDA approves a Mylan ANDA for glatiramer acetate injection 40 mg/mL and 20 mg/mL, AP-rated, substitutable generic versions of Teva...

Comments Sought on Pregnancy Labeling Requirements

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Federal Register notice: FDA requests comments on an information collection extension for Content and Format of Labeling for Human...

7 Recalled, Failed Devices Cost Medicare $1.5 Billion: IG Report

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The HHS Inspector General says that seven recalled or prematurely failed cardiac devices cost Medicare $1.5 billion over nine year...

CGMP Violations in Koreas Dasan E&T

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FDA warns Koreas Dasan E&T Co. about CGMP violations in its production of finished pharmaceuticals.

2 ANDA Guidances Out

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FDA issues two draft guidances clarifying changes made in the recent GDUFA reauthorization.

QS Issues Found in Diasol East Inspection

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FDA warns Diasol East about QS violations in its manufacturing of dialysis liquid and powder dialysate concentrate.

FDA Denies Without Comment Apotex Neulasta Petition

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FDA denies an Apotex petition asking it to set requirements for BLAs referencing Neulasta, and doesnt comment on whether it may ul...

3 MDUFA 4 Guidances Issued

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FDA issues three guidances explaining revised performance goal actions approved in the MDUFA 4 reauthorization for 510(k)s, PMAs, ...