Come out to our Regulatory Coffee Chat networking event near Baltimore/Annapolis, MD. Please join us for this informal event meant to connect our chapter members to each other and build our ...

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 ...

An Iran-linked hacker group called Handala Team has claimed responsibility for an attack that disrupted Michigan-based medical device manufacturer Stryker@s Microsoft systems this week. While the ...

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

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.

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 ...

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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.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as ...

RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as ...

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 ...

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 ...