Uncategorized
FDA releases plan to expedite, promote generic drug development
As part of its effort to increase competition in the prescription drug market, the FDA released a list of drugs that are off-patent and off-exclusivity without approved generics and produced a revised manual of policies and procedures for review of abbreviated new drug applications, including prioritization for generic products.“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Scott Gottlieb, MD, commissioner of the FDA, (Read more...)