Medical Devices
Masimo O3 Regional Oximetry for Neonatal/Infants
FDA clears a Masimo 510(k) for its O3 Regional Oximetry for use on neonatal and infant patients.
FDA General
Latest Federal Register Notices
FDA Webview posts the Federal Register notices for the week ending 6/7/2019.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 6/7/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Workshop on Generating Real-World Evidence
Federal Register notice: FDA announces a 7/12 public workshop entitled Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regul...
Federal Register
Nonalcoholic Steatohepatitis Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for T...
Federal Register
Draft Guide on Enhancing Trial Diversity
Federal Register notice: FDA makes available a draft guidance entitled Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, En...
Medical Devices
Ex-Advanced BioHealing CEO Settles Marketing Suit
Former Advanced BioHealing chairman and CEO Kevin Rakin pays the government $2.5 million to settle False Claims Act allegations that he knowingly allo...
Human Drugs
FDA Hits Pharmasol with Warning Letter on GMPs
FDA releases a 3/14 Warning Letter to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing sig...
Human Drugs
2 New Nucala Administration Options Approved
FDA approves two new methods for administering GlaxoSmithKlines Nucala (mepolizumab) an autoinjector and a pre-filled safety syringe for patients wi...
