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.
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More
The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years. Read More
The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
The FDA is considering a new inspections scoring system that would, for the first time, recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.Read More
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