[ Price : $8.95]
CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar...[ Price : $8.95]
CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment...[ Price : $8.95]
Three congressmen introduce the Alternatives to Animals for Regulatory Fairness Act to reduce animal testing by drug companies.[ Price : $8.95]
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring...[ Price : $8.95]
FDA commissioner Stephen Hahn says the agency has added about 1,000 new staff in fiscal year 2020 due to a streamlined hiring spre...[ Price : $8.95]
FDA issues Adamis Pharmaceuticals a second complete response letter on its NDA for Zimhi, a high-dose naloxone injection product f...[ Price : $8.95]
FDA makes available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Anal...