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Guidance Needed for Drug/Tech Combos: Coalition

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The Clinical Decision Support Coalition calls on FDA to develop a new form of case study guidance to provide the agency view on a ...

Aerie Pharma NDA for Intraocular Pressure Drug

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Aerie Pharmaceuticals files an NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop designed to l...

FDA Cautions Against Ovarian Cancer Screens

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FDA alerts women and doctors to risks associated with tests marketed as ovarian cancer screens.

FDA Clears Invendo Single-use Colonoscope

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FDA clears an Invendo Medical 510(k) for the invendoscopy E200 System, which includes the invendoscope SC200, a sterile, single-us...

Info on Clinical Laboratory Improvement Amendments

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on requests for c...

Comments Sought on HCT/P Regulations

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Federal Register Notice: FDA seeks comments on the information collection requirements for regulations on human cells, tissues, an...

FDA Issues Emergency Use Authorization for Zika Diagnostic

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Federal Register Notice: FDA issues an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus.

FDA Priority Review for Mercks Keytruda in Lung Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatme...

Florida Court Backs Apotex in Biosimilar Patent Case

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The Southern Florida District Court rules that Apotexs proposed filgrastim and pegfilgrastim biosimilar products will not infringe...

FDA Infectious Disease Designation for Taxis Pharmas TXA709

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FDA grants Taxis Pharmaceuticals a qualified infectious disease product designation for TXA709, which targets acute bacterial skin...