Federal Register notice: HHS announces its intent to withdraw FDAs Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.100, Marketed New Drug...
Federal Register notice: FDA sends to OMB an information collection revision entitled Product Jurisdiction and Combination Products 21 CFR Part 3.
Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information to Understand Challenges and Opportunitie...
Three healthcare groups sue the Trump administration to block an HHS/FDA final rule that would permit some drug importation from Canada.
FDA warns AuroLife Pharma about CGMP violations at two of its New Jersey drug manufacturing facilities.
FDA posts a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.
FDA approves an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), a rare genetic disor...
FDA issues a guidance to assist ANDA applicants for complex products to schedule and conduct several types of meetings with agency staff.