Regulatory News In Brief
This article was originally published in The Gray Sheet
ReGen sues FDA
You may also be interested in...
Chlamydia/gonorrhea tests draft guidance
FDA is on the lookout for physicians who promote medical devices for unapproved uses, as well as the companies that contract with them, regulators said last week at a Food and Drug Law Institute meeting
South Korea’s Qurient achieves proof of concept in a Phase II study with its first-in-class antibiotic telacebec for tuberculosis and aims to file a US NDA for the orphan drug.