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The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal s...[ Price : $8.95]
Federal Register notice: FDA announces a 10/4 Oncologic Drugs Advisory Committee meeting to review a World Meds NDA eflornithine t...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Informed Consent: Guidance for Institutional Review Boards,...[ Price : $8.95]
Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medica...[ Price : $8.95]
Three CDER researchers share best practices to reduce deficiencies in regulatory submissions involving real-time release testing f...[ Price : $8.95]
FDA warns Lincoln, RI-based Denison Pharmaceuticals about CGMP violations and manufacturing unapproved new drugs.[ Price : $8.95]
A new CDRH Web page on tips for providing stakeholder comments on guidance documents says the Center prefers comments that are sub...[ Price : $8.95]
FDA clears a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the companys electrophysiology rec...