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Drugmakers want the FDA to provide more details and examples of how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA hopes to cut down on patient-to-patient transmission of blood-borne infections by clearly labeling injectable therapies that are meant to be used multiple times by a single patient as products for “single-patient-use.” Read More
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