FDA sends Dr. Reddys Laboratories an eight-observation Form FDA-483, the third inspection form in six weeks for one of its facilities in India.
FDA releases its latest batch of Warning Letters that includes Deva Holding, Polymer Technology Systems and TG United.
FDA sends Vanda Pharmaceuticals a complete response letter on supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder.
Federal Register notice: FDA announces a 9/12 public workshop entitled FDA Science Forum 2019.
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.