In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...
RICHMOND, Va. (WRIC) — Gov. Glenn Youngkin has issued an executive order that will launch a first-of-its-kind “agentic” artificial intelligence (AI) regulatory review. The pilot program reportedly ...
The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.
RIAs are subject to stringent compliance policies and procedures – fiduciary obligations, disclosure rules, and exams and inspections, to name a few. Often, meeting these requirements eats into the ...
In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...
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Mine managers call for streamlined mining processes
Association of Mine Managers of Zimbabwe (AMMZ) president Abel Makura says the association is engaging with authorities and regulatory bodies to streamline processes in the mining sector. The mining ...
The Department of the Interior’s recent actions to streamline environmental reviews for critical energy projects mark a watershed moment for Wyoming and the entire American West. As chairwoman of the ...
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