The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, ...
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
Groups representing drugmakers and combination product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of ...
Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the U.S. Food and Drug Administration (FDA) under DMF No.
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...
WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...
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