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New FDA PathologAI Initiative

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The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal s...

Panel to Discuss Neuroblastoma NDA

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Federal Register notice: FDA announces a 10/4 Oncologic Drugs Advisory Committee meeting to review a World Meds NDA eflornithine t...

Final Guide on Informed Consent

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Federal Register notice: FDA makes available a final guidance entitled Informed Consent: Guidance for Institutional Review Boards,...

Comments Reopened on Medicated Articles Guide

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Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medica...

Deficiencies in CM and RTRT-D NDA Submissions

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Three CDER researchers share best practices to reduce deficiencies in regulatory submissions involving real-time release testing f...

Multiple Denison Pharmaceuticals Violations

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FDA warns Lincoln, RI-based Denison Pharmaceuticals about CGMP violations and manufacturing unapproved new drugs.

CDRH Prefers Guidance Comments in Table Format

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A new CDRH Web page on tips for providing stakeholder comments on guidance documents says the Center prefers comments that are sub...

CathVision Electrophysiology Algorithms Cleared

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FDA clears a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the companys electrophysiology rec...

Priority Review for Serviers Tibsovo sNDA

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FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic s...

Abortion Drug Can Remain on Market: Appeals Court

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The Fifth Circuit Court of Appeals rules that the abortion drug mifepristone can remain on the market while litigation continues.