FDA accepts for review an Agile Therapeutics NDA resubmission for Twirla (ethinyl estradiol and levonorgestrel transdermal system), an investigational...
FDA says it is looking for volunteers from a broad spectrum of software developers to provide test cases for the software as a medical device precerti...
FDA chief of staff Lauren Silvis says the agency continues to urge congressional reform of the OTC monograph system to encourage more innovation.
FDA approves an EpiBone IND to allow a Phase 1/2 clinical trial of its lead bone product, EpiBone-Craniomaxillofacial, that is being evaluated as a po...
A Texas federal judge approves an injunction closing the Pharm D Solutions drug compounder until it complies with federal law and other requirements.
FDA approves a Mayne Pharma supplemental NDA for Sorilux (calcipotriene) Foam, 0.005% to expand its use in adolescents (aged 12 years and older) with ...
Four House Democrats introduce legislation to increase physician reporting of faulty and unsafe medical devices.
The House Appropriations Committee posts a draft fiscal year (FY) 2020 spending bill that would provide $5.85 billion for FDA $167 million more than ...