Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation in FDA Non-Employee F...
FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.
FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and treating stress urinary...
FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treating opioid overdose.
CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web page and finding false ...
Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applications and recordkeepin...
FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fibrosis due to nonalc...
Federal Register notice: FDA has made available a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigator...