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FDA Clears Gel-e Adhesive Bandage

[ Price : $8.95]

FDA clears a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavil...

FDA Accepts sBLA for Odivo/Yeroy Combination

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FDA accepts a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat in...

Gottlieb Sets 2018 FDA Goals

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FDA commissioner Scott Gottlieb lays out regulatory priorities for 2018 for drugs and medical devices.

FDA Gives Docs Antibiotics Management Tool

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FDA opens a Web site to give doctors antibiotic breakpoint information in a more efficient and timely way.

10 Observations in Shilpa Medicare Inspection

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FDA releases the FDA-483 with 10 observations from an inspection at Indias Shilpa Medicare Limited.

Antibiotic Susceptibility Test Guidance

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FDA issues a guidance on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription syste...

OMB Asked to Extend Info Collection on FDA Drug Communications

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Federal Register notice: FDA sends to OMB an information collection extension request for Data To Support Drug Product Communicati...

Hospitals Suggest Ways to Improve Drug Compounding

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The American Hospital Association urges FDA to take steps to reduce the regulatory burden on hospitals involving compounded drugs ...

Stakeholders Ask REMS Guidance Changes

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Four drug stakeholders ask FDA to revise its draft guidance on REMS format and content.

FDA Draft Guide on NDA/BLA Refuse to File Actions

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Federal Register notice: FDA makes available a draft guidance entitled Refuse to File: NDA and BLA Submissions to CDER.