Webinar: FDA’s New Decentralized Trials Guidance: What Regulatory Professionals Need to Know
Tuesday, June 6, 2023, 12:00pm ET
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FDA finalizes guidance on whole slide imaging approaches for nonclinical studies
The FDA has finalized its thinking regarding the use of whole slide imaging (WSI) in nonclinical toxicology studies. While the final guidance document reflects relatively minor changes from its predecessor, the broader field of digital pathology continues to undergo rapid innovation that warrants careful regulatory consideration.
CDRH hopes to release the QMSR final rule later this year. Here’s why we’re skeptical.
At a recent conference, CDRH Director Jeff Shuren remarked that the publication of the center’s final rule on the transition to a new quality system regulation for medical devices was a top priority for the agency, and that he “hoped” to have it completed by the end of the calendar year. However, according to AgencyIQ’s analysis, a variety of factors make it unlikely that CDRH will be able to realize those hopes.
What we expect the EPA to do in June 2023
In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.
EPA proposes amendments to TSCA new chemicals and to remove exemptions for PFAS and PBTs
EPA has proposed long-awaited amendments to the TSCA review of new chemicals to codify practices in keeping with the 2016 TSCA amendments. In order to improve efficiencies, industry would be required to provide additional data when submitting new chemicals for review.
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