Good Review Management Guidance To Be Tested By “Root Causes” Analysis
FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005
More from Archive
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.’
More from Pink Sheet
The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.