Israelsen GMP Tips: Watch “Wild Card” Law, Use CoA As Legal Documents
• By Jessica Lake
Enforcement actions brought by the Federal Trade Commission against dietary ingredient companies that provide false or misleading certificates of analysis to supplement manufacturers could be an effective mechanism for assuring supply quality, according to Utah Natural Products Alliance Executive Director Loren Israelsen
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
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.
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.
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.