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The drug pricing authority in India added 52 more drugs under price control, including products used to treat pain, cancer, skin disorders and infections, as part of a program to provide life-saving and essential medicine's to the country’s population. Read More
India’s health ministry is proposing to spend more than $280 million to strengthen the country’s national and state drug regulatory systems, with the aim of speeding approval decisions and testing of products. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with U.S.-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
A compounding pharmacy pled guilty to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. 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 good manufacturing practices. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The House late last night approved nearly $1.7 billion in funding for FDA’s drug and biologics activities next year, a slight boost from current levels. Read More
For the first time, a brand drugmaker has defeated a generics firm’s patent challenge through the U.S. Patent and Trademark Office’s internal review board process, which started in 2012. Read More
The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
A large public employer has filed a federal class-action lawsuit accusing Gilead Sciences of price gouging with its $1,000-a-pill hepatitis C drug Sovaldi. Read More