The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal studies are encouragi...
Federal Register notice: FDA announces a 10/4 Oncologic Drugs Advisory Committee meeting to review a World Meds NDA eflornithine tablets for reducing ...
Federal Register notice: FDA makes available a final guidance entitled Informed Consent: Guidance for Institutional Review Boards, Clinical Investigat...
Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medicated articles.
Three CDER researchers share best practices to reduce deficiencies in regulatory submissions involving real-time release testing for dissolution and/o...
FDA warns Lincoln, RI-based Denison Pharmaceuticals about CGMP violations and manufacturing unapproved new drugs.
A new CDRH Web page on tips for providing stakeholder comments on guidance documents says the Center prefers comments that are submitted in a table fo...
FDA clears a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the companys electrophysiology recording system.
