Global Protection was granted marketing authorization for the first condoms specifically indicated to help reduce transmission of sexually transmitted infections during anal intercourse, the U.S. FDA said.
- The product, which will be marketed as the One Male Condom, was reviewed through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type
To view the source of this information click
To contact the reporter on this story:
To contact the editor responsible for this story:
© 2022 Bloomberg L.P. All rights ...
Learn more about Bloomberg Law or Log In to keep reading:
Learn About Bloomberg Law
AI-powered legal analytics, workflow tools and premium legal & business news.
Already a subscriber?
Log in to keep reading or access research tools.