Federal Register notice: FDA makes available a guidance on studies to evaluate the metabolism and residue kinetics of veterinary drugs.
Federal Register notice: FDA sends to OMB an information collection extension for evaluating the agencys review transparency and communications involv...
Sun Pharmaceutical Industries moves past previous GMP issues at its once-troubled Halol, India plant after FDA classifies a recent inspection there as...
Genus Lifesciences petitions FDA seeking an acceptance rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product.
FDA clears an OrthoPediatrics 510(k) for its new PediFoot Deformity Correction System for pediatric foot fractures and deformities.
FDA approves a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia.
FDA Review posts the Federal Register notice for the week ending 8/16/2019.