FDA appoints global, IT heads: The agency has chosen Lou Valdez as associate commissioner for international programs and Lori Davis as chief information officer. Valdez will lead the agency's further international expansion, with office openings planned for India, Latin America and the Middle East, FDA says Jan. 12. Melinda Plaisier stepped down as associate commissioner for international programs in October to become director of the Central region office in FDA's Office of Regulatory Affairs (1"The Tan Sheet" Dec. 8, 2008, p. 8). Davis has been deputy CIO since November 2007 and will now drive FDA's multi-year information technology modernization program, which will improve import and food protection by enhancing system interoperability
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.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
