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FTC Sets Drug Competition Workshop

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The Federal Trade Commission sets an 11/8 workshop on drug market competition with an address by FDA commissioner Scott Gottlieb.

Prior Approval Supplement Submission Guidance

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FDA issues a guidance on submitting to prior approval supplements and their amendments to FDA.

Public Meeting on Topical Dermatological ANDAs

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Federal Register: FDA announces a 10/20 public workshop on Topical Dermatological Generic Drug Products: Overcoming Barriers to De...

Common Technical Document Guidance Out

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FDA issues a guidance with recommendations for preparing the Common Technical Document for the Registration of Pharmaceuticals for...

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...