US FDA invites companies to participate in drug names pilot
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is inviting pharmaceutical and biotech companies to participate in its much-anticipated pilot programme on the evaluation of drug proprietary names. Under the pilot, companies will be able to check in advance whether their proposed invented trade names are likely to be acceptable to the FDA1,2.
You may also be interested in...
COVID-19 Vaccine Dosing: Pharma Says Follow The Science As It Gathers Data
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.
India Permits Sale Of Some Devices Beyond Licensing Deadline
Existing importers and manufacturers of certain medical devices can continue marketing their products for six months or until the Indian medtech regulator makes a final decision on their pending licensing applications.
Australia Considers Redefining Central Circulatory System To Align With EU
Differences between how Australia and the EU define “central circulatory system” has resulted in different risk classification levels being assigned to some devices in the two jurisdictions.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: