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Federal Register

Model-Informed Drug Development Meetings Continue

Federal Register notice: FDA announces the continuation of its Model-Informed Drug Development Paired Meeting Program as part of the recent user fee r...

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Federal Register

Correction Notice on Advisory Committee Charter Renewal

Federal Register notice: FDA corrects a 12/13/2022 notice entitled Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal.

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Human Drugs

Standardizing REMS Information in SPL

CDER Office Medication Error Prevention and Risk Management director Claudia Manzo describes the change in REMS format to SPL.

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Human Drugs

Valisure FDA-483 on Lab Practices Released

FDA posts a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection....

Biologics

Evolving Covid Variants Challenge Future Vaccines: Marks

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

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Human Drugs

Spectrum Labs Recall 3 Epinephrine Lots

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

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Medical Devices

New AI Transparency Minimums Needed: Column

Two AI experts say there should be new baseline performance standards incorporated in algorithms that are submitted to FDA for review, as protection a...

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Medical Devices

FDA, Health Canada Open eSTAR Pilot

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

Human Drugs

AAM Appreciates Sameness Evaluation Guidance

The Association for Accessible Medicines makes several recommendations it says will improve an FDA draft guidance on an evaluation of the sameness of ...

Medical Devices

AdvaMed Recommendations on Consensus Standards

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