FDA officials questioned why the generic industry feels its pharmacovigilance information is sufficient to suggest labeling changes in other countries, but inadequate for the same task in the U.S., which would be required under the proposed generic labeling reg.
A number of generic company representatives said during a March 27 public meeting on the controversial proposed rule that it would be inappropriate to allow them to propose and make...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?