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.
CDRH holds a second listening session on its new Digital Health Center of Excellence and examines whether it is pursuing the most appropriate goals.
FDA extends from 24 to 36 months the expiration date for 42 lots of Cutaquig if they are stored at a cooler temperature.