NSF International announces May 30 its good manufacturing practices readiness program, "One Step Ahead," which includes an online service center to help manufacturers prepare for the GMPs. NSF will audit facilities and note any non-conformances, giving firms opportunities to take corrective action before FDA audits. NSF's program offers a source book containing standard operating procedure templates and a trial self-audit tool. FDA and the Office of Management and Budget announced GMPs received final clearance from OMB on May 9 (1"The Tan Sheet" May 14, 2007, p. 5)...
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.’
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
