CDER reminds industry that beginning 5/5 drug sponsors must submit applications for new drugs, generic drugs, biologics, biosimilars, and drug master ...
Three senators say HHS secretary Tom Price should certify some drugs for importation from Canada.
FDA warns Chinas Zhejiang Bangli Medical Products about CGMP violations in its production of finished pharmaceuticals and its limiting of an FDA inspe...
A review of new enforcement statistics shows that Warning Letters issued in fiscal year 2016 fell by 15% compared with such letters issued in FY 2015.
FDA clears a Spinal Simplicity 510(k) for the Minuteman G3-R spinal implant, which is intended to be implanted using a lateral approach.
Former FDA commissioner Robert Califf says there are a number of things the Trump administration should be aware of as it attempts to reduce regulatio...
CDER issues a MAPP on good review management principles and practices during IND development and review.
FDA clears a Centric Medical 510(k) for the Metatarsal Hemi Implant System, intended for use in the treatment of patients with degenerative and post-t...