Comment period extended to Dec. 8 for FDA draft guidance on "Stability Testing of Drug Substances and Drug Products," according to an Aug. 24 Federal Register notice. The former deadline was Sept. 9, but the draft is "long and complex and introduces a number of new issues," justifying a longer period for public comment, FDA says. The guidance offers recommendations concerning stability studies conducted to support NDAs, ANDAs, INDs, BLAs, PLAs and supplements ("The Tan Sheet" June 22, p. 21)...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
