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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
Facing calls for congressional inquiries and investigations by prosecutors in New York and Massachusetts, Valeant Pharmaceuticals officials say the outlook for the drug industry in 2016 is for lower price increases. Read More
This week is shaping up to be a busy one for FDA reviewers, with decisions due on four NDAs for drugs to treat hyperkalemia, chronic pain and cancer. Read More
For the second time this year, Otsuka has sued the FDA for loss of patent protection for its schizophrenia drug Abilify — this time to reverse the agency’s approval of Alkermes’ Aristada. Read More
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