CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar User Fee reauthoriz...
CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment pilot project that ...
Three congressmen introduce the Alternatives to Animals for Regulatory Fairness Act to reduce animal testing by drug companies.
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analy...
FDA commissioner Stephen Hahn says the agency has added about 1,000 new staff in fiscal year 2020 due to a streamlined hiring spree authorized by the ...
FDA issues Adamis Pharmaceuticals a second complete response letter on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid o...
FDA makes available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices.
Federal Register notice: FDA makes available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Analysis Programs.