Webinar: What you need to know about FDORA, the new FDA reform law
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Regulatory Explainer: The dozens of FDA reforms contained in Congress’ omnibus funding bill
The 4,155-page full government funding measure released early on December 20th includes dozens of policy provisions that will have a significant impact on the life sciences industry and the FDA. In this explainer, we set out to analyze the FDA-related provisions of this mega-bill.
CDER unveils new guidance agenda for 2023, with 42 new policies planned
FDA’s Center for Drug Evaluation and Research (CDER) has unveiled a new guidance agenda covering the guidance documents it potentially plans to release in 2022. While many of the documents are holdovers from its 2022 guidance agenda, there are also 42 new additions to the list of 98.
Navigating the chemicals transition pathway
The European Commission published its long-anticipated Transition Pathway for the Chemical Industry. The pathway consists of eight building blocks incorporating nearly 200 industry action items. These eight components and their most industry-relevant action items are summarized and analyzed here.
ECHA publishes 2023 work program
The ECHA has issued its programming document for the 2023-2026 period, including a work program detailing the agency’s priority actions for the coming 24 months. While ECHA’s long-term objectives are essentially the same as last year’s, its near-term goals reveal an increased workload.
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