[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...[ Price : $8.95]
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...[ Price : $8.95]
FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....[ Price : $8.95]
FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...[ Price : $8.95]
FDA publishes an updated Global Unique Device Identification Database guidance.[ Price : $8.95]
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.[ Price : $8.95]
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Pro...[ Price : $8.95]
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.