RAPS Euro Convergence unites regulatory affairs professionals and industry partners to share and collaborate on solutions for the improvement and advancement of healthcare in Europe.

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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 ...

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With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA ...

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 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 ...

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 ...

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources ...

The US Food and Drug Administration (FDA) has published three draft guidances on developing cell and gene therapies (CGT) to treat rare diseases, conducting postapproval CGT studies, and using the ...

This article provides an overview of FDA@s medical device Unique Device Identification System Final Rule1 and explains why including UDIs in health information and in device recalls can improve ...