FDA extends its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil) after receiving an information request letter f...
Federal Register notice: FDA publishes a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more...
FDA says it will open notice-and-comment rulemaking to analyze the impact of a memorandum of understanding between it and states on the distribution o...
Three stakeholders comment on an FDA draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.
FDA grants Noninvasix a breakthrough device designation for its LivOx Central Venous Oxygenation Monitor for monitoring central venous oxygen saturati...
Federal Register notice: FDA announces a 3/22 virtual public meeting on the biosimilar user fee programs enhanced review transparency.
CDER Office of Prescription Drug Promotion senior social science research analyst Katherine Aikin explains the work her unit does on patient-level ind...
The CDER Office of Pharmaceutical Quality reports on its 2021 core function activities and efforts to carry out White House recommendations for improv...