26
May

New Recommended PDE Limits for Three Solvents Proposed by ICH

Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).”  The recommendations are based on the testing parameters established for developing permitted […]

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30
Jul
Girlfriends using a map on station

ICH Q12 – Ready or Not, Here it Comes!

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum).  This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and […]

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