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Valisure FDA-483 on Lab Practices Released

[ Price : $8.95]

FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/2...

Evolving Covid Variants Challenge Future Vaccines: Marks

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Writing in a JAMA Viewpoint, CDER director Peter Marks et al say that continuing to develop variant-specific vaccine boosters is i...

Spectrum Labs Recall 3 Epinephrine Lots

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Spectrum Laboratory Products recalls three lots of epinephrine (L-adrenaline) USP due to product discoloration complaints.

New AI Transparency Minimums Needed: Column

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Two AI experts say there should be new baseline performance standards incorporated in algorithms that are submitted to FDA for rev...

FDA, Health Canada Open eSTAR Pilot

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FDA says it is partnering with Health Canada for an eSTAR submission pilot to involve nine participants.

AAM Appreciates Sameness Evaluation Guidance

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The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation...

AdvaMed Recommendations on Consensus Standards

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AdvaMed sends FDA five recommendations about the appropriate use of consensus standards.

NDA/BLA Approval Metrics Take a Hit in 2022

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CDERs first cycle approval rate for NDAs/BLAs approved in 2022 fell from 86% in 2021 to 76% (28 of the 37 novel approvals) in 2022...

Info Collection on Animal Minor Use/Species

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Federal Register notice: FDA sends to OMB an information collection extension entitled Reporting Associated with Designated New An...

Cell/Tissue Manufacturing Deviation Reporting

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Federal Register notice: FDA sends to OMB an information collection extension entitled Cellular and Tissue-Based Product Deviation...