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Federal Register notice: FDA sends to OMB an information collection revision entitled Product Jurisdiction and Combination Product...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information to Understand Challen...[ Price : $8.95]
Three healthcare groups sue the Trump administration to block an HHS/FDA final rule that would permit some drug importation from C...[ Price : $8.95]
FDA warns AuroLife Pharma about CGMP violations at two of its New Jersey drug manufacturing facilities.[ Price : $8.95]
FDA posts a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.[ Price : $8.95]
FDA approves an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), ...[ Price : $8.95]
FDA issues a guidance to assist ANDA applicants for complex products to schedule and conduct several types of meetings with agency...[ Price : $8.95]
CDRH holds a second listening session on its new Digital Health Center of Excellence and examines whether it is pursuing the most ...