RAPS

Asia-Pacific Roundup: India’s CDSCO posts draft legislation on manufacturing change approvals, notifications

India@s Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.
RAPS

Regulatory Intelligence 101, Third Edition

Comprised of 25 chapters from 30 experts from seven different countries, this edition incorporates a global overview of regulatory intelligence.
RAPS

FDA releases draft guidance on use-related risk analysis for combo products

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.
RAPS

150 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2025 Combination Products in the EU

Brussels — 30 January 2025 — DIA and the Regulatory Affairs Professionals Society (RAPS) just wrapped "2025 Combination Products in the EU," a summit convening 28-29 January at the Radisson Grand ...
RAPS

The Essential List of Regulatory Authorities in Europe

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RAPS

AI in drug development: FDA draft guidance addresses product lifecycle, risk

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RAPS

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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RAPS

FDA issues new unit-dose repackaging guidance

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RAPS

FDA trims reserve testing quantity requirements

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RAPS

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 ...
RAPS

Trends and developments in dietary supplement class action lawsuits in the US

The dietary supplement industry in the US faces increasing class action risk driven by labeling, testing, and compliance claims. Courts continue to apply the reasonable consumer standard when ...