Federal Register notice: FDA submits for OMB approval an information collection extension request for Postmarketing Safety Reports for Human Drug and ...
A new report on cutting drug prices from the White Houses Council of Economic Advisers recommends innovation cost reductions through FDA reforms, amon...
FDA and the Nuclear Regulatory Commission approve NorthStar Medical Radioisotopes RadioGenix System to produce Tc-99m, the most widely used medical im...
FDA touts publication of 57 new and revised product-specific guidances to help generic drug makers know what is required to obtain ANDA approval for a...
United Therapeutics submits a fifth petition on its Tyvaso to ensure that FDA considers the issues the company has raised.
FDA sends Sandoz a complete response letter, denying approval for its proposed generic copy of GlaxoSmithKlines Advair Diskus (fluticasone propionate/...
FDA approves a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis.
FDA clears a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the companys polymerase chain reaction testing platform.