Webinar: What industry professionals need to know about the regulation of PFAS in the U.S. and EU.
September 29, 2022 | 1:00 PM ET
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CDRH finalizes electronic submissions guidance with extended exemption provisions
Working to complete its MDUFA IV commitments, the FDA has finalized guidance on using an electronic submission template system for 510(k) submissions with an implementation date of October 2023. Following some concerns from industry about the technical limits of the template system, the final guidance adds exemptions from using the electronic templates, but maintains that the agency does not intend to issue waivers.
Behind schedule, FDA releases guidance describing process for obtaining access to generic drug samples
Published nearly a year after the FDA and HHS anticipated, a new draft guidance document published by the FDA aims to clarify how the process to request a Covered Product Authorization (CPA) works. The process is intended to make it easier for generic drug companies to obtain samples of certain drugs that are necessary to conduct the testing needed to obtain FDA approval. But as AgencyIQ found, FDA’s guidance is short on answers to a lengthy list of important questions.
EU Commission invites feedback on its vision of restructured European Chemicals Agency
The European Commission has launched a call for evidence via the “Have your say” portal, inviting public feedback ahead of the EU executive’s upcoming legislative initiative for a stand-alone “founding regulation” aimed at updating the ECHA roles and responsibilities. The Commission plans to overhaul the agency’s structure the initiative is also expected to redefine the way the agency’s operations are financed.
Sixth Circuit Grants Review of PFAS Class Action Lawsuit
Defendants in an Ohio-based PFAS lawsuit received a mid-litigation win when the Sixth Circuit Court of Appeals approved the defendants’ petition to review the trial court’s class certification of a wide group of individuals. The Sixth Circuit will now review the decision to determine whether or not the trial court properly certified the class.
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