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Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Stud...[ Price : $8.95]
A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vand...[ Price : $8.95]
Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action i...[ Price : $8.95]
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Federal Register notice: FDA reopens the comment period for a 6/8 draft guidance on demonstrating bioequivalence for Type A medica...[ Price : $8.95]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...