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FDA Publishes Drug Filing Checklists, Issues First-Ever Emergency Use for Animal Drug

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
BioSpace

FDA’s Circle of Trust Is Shrinking, Making Many Decisions Feel Like ‘Fiat’

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.
newscase

Spruce Biosciences Revises Regulatory Submission Timeline for Key Drug Candidate

Spruce Biosciences Inc has announced a revised schedule for its regulatory submission of TA-ERT, a potential treatment for Sanfilippo syndrome type B. While the ...

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...