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Class 2 Designation for Organophosphate Test System

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Federal Register notice: FDA classifies the organophosphate test system into Class 2 (special controls).

FDA Grants, Denies Parts of Examination Glove Petition

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FDA grants a Public Citizen petition to ban cornstarch powder in surgeons and patient examination gloves and denies its request to...

FDA Digital Health Framework Raises Questions: Post

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A Health Affairs blog post raises several questions about major policy changes in the FDA Digital Health Innovation Action Plan.

Public Citizen Warns Against Azar at HHS

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Public Citizen says that former Lilly executive Alex Azar, a potential candidate as HHS secretary, opposes steps to restrain drug ...

Bumper Ads Can Help Recall: CMI

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Media resource CMI says YouTube bumper ads can be used strategically to tease new products, increase awareness of existing product...

CDER Inspection/Review Leader Doleski Leaves for Sanofi

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After 28 years at FDA, CDER Office of Process and Facilities (OPF) acting deputy director David Doleski leaves to accept the posit...

FDA Priority Review for Lynparza sNDA for Breast Cancer

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FDA accepts for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in certain patients wit...

Akorn 483s Released

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FDA releases two identical FDA-483s issued to Akorn, Inc., with three inspection observations.

Pacira sNDA Resubmitted on Exparel for Pain

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FDA accepts a Pacira Pharmaceuticals supplemental NDA resubmission seeking expansion of its Exparel (bupivacaine liposome injectab...

Comments Sought on Device Tracking Collection

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Federal Register notice: FDA seeks comments on an information collection extension request for Medical Devices; Device Tracking 2...