Medical Devices
Phillips Respironics Recalls Triology EVO Ventilators
Philips Respironics recalls its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect.
FDA, India Stop 500 Illicit Product Shipments
FDA says a joint enforcement operation conducted with India stopped about 500 shipments of illicit and potentially dangerous unapproved prescription d...
Human Drugs
GDUFA 2019 Science and Research Report
CDER publishes a FY 2019 report detailing accomplishments under the GDUFA Science and Research Program.
Changes Sought in Draft Combination Product Bridging Guidance
Boehringer Ingelheim asks for better alignment of examples in an FDA bridging draft guidance.
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28 No Longer Marketed ANDAs Withdrawn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Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combin...
