The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...

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The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three years for companies that establish manufacturing operations to manufacture finished generic ...

A leadership summit dedicated to regulatory affairs Learn business and leadership lessons from faculty at one of the world's most prestigious business schools.

The European Commission has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR).

Understand how labeling decisions fundamentally shape your promotional strategy. This event will tackle the common challenges of translating complex regulatory language into compelling yet compliant ...

Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...

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 ...

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 ...

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 ...

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 ...