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FDA Worried About Sole-sourced Products from Puerto Rico: Gottlieb

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FDA commissioner Scott Gottlieb says the agency is very concerned about 13 sole-sourced drug products that are made in Puerto Rico...

Patient Engagement Advisory Committee Meeting Amendments

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Federal Register notice: FDA announces amendments to an earlier notice that provided details of a 10/11-12 Patient Engagement Advi...

Essure Postmarket Study Barely Off the Ground: Post

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ClassAction.com says an FDA-mandated postmarket surveillance study of Bayers Essure birth control device has enrolled only one pat...

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...

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.