Reversal of downward enforcement trend expected after President Obama's team takes reins at FDA. After eight years of declining inspection activity, field staffing and warning letter issuance, industry is bracing for change. Obama demands "full review" of FDA over peanut recall. More criminal prosecutions expected. Congress plies agency with money for overseas inspections. FDA headquarters could unleash warning letters. New investigators will learn domestically while seasoned ones retire or head overseas. Focus of warning letters begins shifting abroad. Form 483 reports and warning letters continue to raise the same key issues. Production record review, data integrity, process validation concerns highlighted. Issues raised in 18 FY 2008 drug GMP warning letters detailed in chart beginning on page 12.
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.’
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
