Figure 1. Preclinical testing and clinical testing must be part of this generic product development cycle (click to enlarge). Contract research organizations (CROs) used to be considered premarket- or ...
On Thursday, the Food and Drug Administration (FDA) publicly called out companies charged with blocking the development of generic drugs. According to generic manufacturers, brand name manufacturers ...
Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
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