FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.
FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Ivenix Infusion System.
FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.
Four stakeholders respond to an FDA request for comment on guidance best practices.
Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match congressional intent in ...
Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic Metabolic Diseases ...
FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment for Niemann-Pick di...
FDA approves Hugels Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.
