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Federal Register notice: FDA requests comments on an information collection extension for Content and Format of Labeling for Human...[ Price : $8.95]
FDA warns Koreas Dasan E&T Co. about CGMP violations in its production of finished pharmaceuticals.[ Price : $8.95]
FDA issues two draft guidances clarifying changes made in the recent GDUFA reauthorization.[ Price : $8.95]
FDA warns Diasol East about QS violations in its manufacturing of dialysis liquid and powder dialysate concentrate.[ Price : $8.95]
FDA denies an Apotex petition asking it to set requirements for BLAs referencing Neulasta, and doesnt comment on whether it may ul...[ Price : $8.95]
FDA issues three guidances explaining revised performance goal actions approved in the MDUFA 4 reauthorization for 510(k)s, PMAs, ...[ Price : $8.95]
The 9th Circuit Court of Appeals declines to rehear a whistleblower case involving three Gilead HIV drugs.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is making changes to make it easier for patients to gain access to experimental th...