We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
Two domestic manufacturers and one in the territory of Puerto Rico have been called out by the FDA over inspection findings covering a diverse array of GMP concerns. Read More
Despite appeals, the UK’s drug pricing watchdog has held firm against reimbursing Vertex Pharmaceuticals’ cystic fibrosis drug Orkambi, once again noting its modest short-term benefits to lung function and unknown long-term improvements. Read More
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding. Read More
British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More