FDA posts a draft guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Consideratio...
Federal Register notice: FDA withdraws approval of 24 ANDAs from multiple applicants.
Two stakeholders give FDA feedback on agency proposals to revamp the 510(k) program, cautioning that it not take steps that could mislead patients.
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.