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Brazil’s Anvisa has released guidelines on biological controls, drug manufacturing and clinical trials to harmonize with international standards. Read More
The FDA dealt Shire’s promising dry eye treatment lifitegrast a setback, requesting an additional clinical study and more product quality information just days before the drug’s anticipated approval date. Read More
The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. 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