The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...

The move, highlighted on FDA@s mifepristone information webpage and in updates to an associated question-and-answer (Q@A) page on 16 December, makes permanent the eased restrictions permitted during ...

Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...

This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and ...

Member: $0 | Nonmember: $50The European Artificial Intelligence (AI) Act is one of the most challenging new regulations facing manufacturers. The act introduces new concepts, like human oversight and ...

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic (s) and/or demonstrated competence related to the topic (s). Higher-level concepts are ...

The US Food and Drug Administration’s (FDA) office responsible for approving cancer therapies has been renamed the Office of Oncologic Diseases (OOD) and restructured to add new divisions, the agency ...

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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 Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

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 ...

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 ...