On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug ...
The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...
In the February 2017 issue of Pharmaceutical Technology, the authors of "Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results