FDA approves a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular ...
Intellipharmaceutics says it will try to resolve concerns raised by FDA advisors about its Rexista abuse-deterrent opioid.
FDA commissioner Scott Gottlieb announces two new CDRH initiatives to develop more appropriate regulatory approaches to digital health products.
Federal Register notice: FDA announces a new organizational structure for the Office of the Medical Products and Tobacco to establish the Oncology Cen...
FDA medical reviewers say that the Dynavax Heplisav-B hepatitis vaccine is effective but may have safety issues.
FDA commissioner Scott Gottlieb says the agency will postpone sending reduction-in-force notices to staff who are funded by user fees until 9/30 unles...
A Hyman, Phelps & McNamara petition asks FDA to require an explanatory footnote in the Synergy labeling for Trulance indicating that diarrhea adverse ...
Federal Register notice: FDA announces the availability of a guidance on IRB Waiver or Alteration of Informed Consent for Clinical Investigations Invo...