Human Drugs
Savings Not Likely in FDA Drug Import Proposal: Analysis
Manatt Health senior advisor Ian Spatz questions the viability of an FDA proposal to permit states to import drugs from Canada.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/14/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/17/2020.
Federal Register
28 No Longer Marketed ANDAs Withdrawn
Federal Register notice: FDA withdraws approval of 28 ANDAs from multiple applicants.
Federal Register
Comments Extended on Combo Product Bridging Guide
Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combin...
Medical Devices
CDRH Workshop on Computational Modeling Practices
CDRH announces a 4/13-15 public workshop entitled Towards Good Simulation Practices in Health Technologies that will discuss modeling and simulation p...
FDA General
FDA Docket Seeks Data/Info on Vaping Injuries
FDA establishes a docket to obtain data and information on vaping-related lung injuries to help identify and evaluate additional steps the agency coul...
Human Drugs
Sellas Nelipepimut-S Phase 3 Study in Breast Cancer
Sellas Life Sciences Group says that after gaining FDA feedback, it has finalized the design and plan for a Phase 3 study of nelipepimut-S vaccine in ...
Medical Devices
Bluegrass Vascular De Novo for Catheter System
FDA grants Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System.
