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48 Attorneys General Prod FDA on Opioid Abuse

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Attorneys General from 48 states ask FDA commissioner Stephen Hahn to provide a progress report on recent steps the agency has tak...

FDA Regulatory Science Report Signals Top Priorities

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A new FDA report identifies four regulatory science strategic initiatives for 2021 that includes unleashing the power of data, and...

Comments Sought on Antimicrobials Used in Feed Paper

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Federal Register notice: FDA requests comments on a document entitled Potential Approach for Defining Durations of Use for Medical...

Industry Reps Sought for Mammography Panel

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Federal Register notice: FDA seels industry organizations interested in participating in the selection of nonvoting industry repre...

Info Collection for Fellowship/Traineeship Programs

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Federal Register notice: FDA seeks comments on a proposed Collection of Information for Participation in FDA Non-Employee Fellowsh...

FDA Chief Counsel Amin Resigns

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FDA chief counsel Stacy Cline Amin resigns after leading the agencys legal shop for over two years.

Fresenius Kabi Recalls 1 Lot of Ketorolac Tromethamine

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Fresenius Kabi USA recalls one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the prese...

sNDA for Jardiance to Reduce Cardiovascular Death/Hospitalization

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FDA accepts a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) for reducing the risk of cardiovas...

Boston Scientific Recalls Lotus Edge Aortic Valve

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Boston Scientific recalls all unused inventory of its Lotus Edge Aortic Valve System due to complexities associated with the produ...

20 Drug Determinations on ANDA Availability

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Federal Register notice: FDA determines that 20 drug products were not withdrawn from sale for reasons of safety or effectiveness,...