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India’s drug regulatory authority has set up a three-month training program for assistant drug inspectors that will run through the end of this year, as the agency works to ramp up their skill sets. Read More
The FDA has quietly removed a September 2014 warning letter issued to Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel. Read More
Brazil’s Anvisa has released guidelines on biological controls, drug manufacturing and clinical trials to harmonize with international standards. Read More
Democratic presidential candidate Hillary Clinton joined the growing chorus of lawmakers and others outraged over Turing Pharmaceuticals’ price hike on Daraprim, pressing the FDA and FTC Monday to broaden access to less expensive drugs. Read More
The FDA’s Office of Planning is calling for better coordination and communications between CDER and CDRH to facilitate reviews of a growing tide of combination therapies. Read More