RAPS

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.
RAPS

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 ...
RAPS

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FDA releases new draft guidance on sponsor role for safety reporting requirements

The US Food and Drug Administration (FDA) has released a new draft guidance for sponsors on safety reporting requirements and assessments for investigational new drug application (IND) and bio ...
RAPS

Oligonucleotides: EMA drafts new guideline on manufacturing and development

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Fundamentals of Pharmaceutical and Biologics Regulations (subscription)

A new RAPS digital experience is coming! Parts of our website will be inaccessible between Saturday, 28 March and Wednesday, 1 April during the migration. These services include: the RAPS Marketplace, ...
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The Essential List of Regulatory Authorities in Europe

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AI in drug development: FDA draft guidance addresses product lifecycle, risk

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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 ...
RAPS

Expanded Access Programs for Medical Devices

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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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