Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Guidance Underscores FDA Practice Of Letting TEAs Steep
The viability of time and extent applications as a route to market for new OTC ingredients continues to wane in light of new final guidance on the process.
More from Archive
• By
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
• By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
• By
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
• By
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
• By
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.