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.
Federal Register notice: FDA announces a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss the strains to be include...
