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FDA officials: High-quality data is essential for AI tools for generic drugs

ROCKVILLE, MD @ Robert Lionberger, director of the US Food and Drug Administration@s (FDA) Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), emphasized the critical need ...
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FDA finalizes safety reporting guidances for sponsors and investigators

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies.
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Regulatory Intelligence 101, Third Edition

The third edition of Regulatory Intelligence 101 was developed for all regulatory professionals who generate regulatory intelligence, particularly those who deliver this key service to others in their ...
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Recon: Digital health, device leaders leave FDA; Walmart, Target get warning letters for recalled infant formula

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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Asia-Pacific Roundup: New Zealand’s Medsafe finalizes bioequivalence guidelines

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its revised guidance on running studies to show products are bioequivalent.
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10-to-1: HHS solicits comments on regulations to eliminate under Trump EO

Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...
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FDA issues long-awaited device remanufacturing guidance

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FDA finalizes guidance on microneedling devices

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FDA issues new standards for DTC prescription drug ads

Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting ...
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The Critical Role of Thickeners in the Therapeutic Medical Management of People with Dysphagia

The regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...
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Trump's 10-for-1 order puts pressure on FDA to find regulations to nix

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...
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Thousands of FDA staff fired in latest RIF

Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...