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 ...
For today’s regulatory professionals, continuous audit readiness is essential. With evolving standards like ICH E6 (R3) and increased global scrutiny, being inspection-ready every day ensures ...
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 ...
It can be challenging to ensure standard language is used when writing regulatory and medical documents, especially when every agency and customer has their own rules. This session explores how to ...
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 European Artificial Intelligence (AI) Act is one of the most challenging new regulations facing manufacturers. The act introduces new concepts, like human oversight and data management, that ...
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 ...
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 US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both ...
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 ...
John Farley has been appointed director of the Office of Infectious Diseases (OID) in the Center for Drug Evaluation and Research’s Office of New Drugs (OND). He had been acting director of OID since ...
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