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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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Oligonucleotides: EMA drafts new guideline on manufacturing and development

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FDA releases new draft guidance on sponsor role for safety reporting requirements

The US Food and Drug Administration (FDA) has released a new draft guidance for sponsors on safety reporting requirements and assessments for investigational new drug application (IND) and bio ...
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Generic industry against giving fee breaks to firms setting up operations in the US

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations ...
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EMA issues guidelines on quality, therapeutic equivalence of inhaled drugs

The European Medicines Agency (EMA) has released a guideline on assessing the quality of inhaled and nasal medicines, as well as a guideline on demonstrating therapeutic equivalence (TE) of orally ...
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Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective

The print version of Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective is out of stock. Stay tuned for a brand new edition arriving April 2026. You can still purchase an e ...
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Fundamentals of Pharmaceutical and Biologics Regulations (subscription)

Subscribe and get the latest pharmaceuticals and biologics fundamentals as they release with this three-year subscription.
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Recon: Pfizer plans to submit Lyme vaccine despite primary endpoint miss; FDA approves BMS’ Hodgkin’s lymphoma drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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7-year FDA review finds improved GCP compliance

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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FDA issues new unit-dose repackaging guidance

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FDA trims reserve testing quantity requirements

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9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

Tweet Deck Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in ...