Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action indicated results may...
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Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medicated articles.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...
