...issued to foreign drug manufacturers in FY 1997 dropped by two-thirds from the previous year. The inspection performance declined for domestic firms, which received 50% more agency warnings than in FY 1996. Warning letters to oral solid manufacturers correspond with recall actions during FY 1997. Failure investigations, stability programs, and process validation remain key FDA compliance concerns. HPLC testing and labeling/ packaging procedures are also on the agency’s radar screen. [The drug cGMP warning letters issued in FY 1997 are listed on pp. 8-16. The listing includes the recipient's name, letter date, plant location and a description of the problem areas cited.
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.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
