Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Bliley Requests FDA Plan To Link Bulk Drug Imports With GMP Compliance
Rep. Bliley (R-Va.) is asking FDA to formulate a plan to provide import inspectors with access to good manufacturing practices compliance information to determine whether bulk drugs should be detained.
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
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
• By
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
• By
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.