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.
With the launch of the FDA’s new Office of Pharmaceutical Quality, all ANDA filers are now eligible for the OPQ’s new real-time communications program – the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
The FDA approved Impax Labs’ Parkinson’s disease drug Rytary after the drugmaker agreed to not use a troubled manufacturing facility for production. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
Manufacturers are urging the FDA to ax three proposed quality metrics related to annual product reviews that would measure a facility’s quality culture, claiming they are too burdensome, unnecessary and confusing. Read More
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with GMPs. Read More
In 2014 the FDA laid the groundwork for an unprecedented overhaul in the next few years in how the agency will measure pharmaceutical quality and conduct inspections. This is a look back at 2014 and the year ahead. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls. Read More