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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. The device description should include information about the current state of the art treatment options and any alternative device choices. Appendix A.2

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Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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Analysis Chemical Thank You What we expect the EPA to do in April 2024

Agency IQ

EPA also proposed an additional set of CO2 standards for HD vehicles that would begin to apply in MY 2028, with progressively more stringent standards each model year through 2032. Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal.

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Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.