FDA Pre-Emption Wins On Appeal
Lawsuits brought against GlaxoSmithKline and Pfizer over "failure to warn" claims for their antidepressant drugs are pre-empted by FDA's authority over labeling, the Third Circuit U.S. Court of Appeals has ruled. But industry's liability risks will likely be determined more by an upcoming Supreme Court case
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
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
Despite pushback by industry, the government is standing by its new statutory scheme rebate rates for branded medicines, including one that doubles the rate that companies must repay on the sales of newer products to the National Health Service to 31.3%.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.