Simplifying Global Compliance
Four democratic senators introduced legislation aimed at ending “predatory” pricing of insulin and other life-saving drugs. The bill would give HHS authority to block any price increases on drugs that it deems “unjustified.” Read More
A month after a scathing congressional report hit Kaléo for hiking prices for its opioid antidote by 600 percent, the company announced it will release a lower-cost generic version of its auto-injector in 2019. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines at its Dec. 10-13 meeting for approval by the European Commission. Read More
Indian drug manufacturer SkyLark CMC drew a warning letter from the FDA by denying the agency investigator access to its manufacturing facility in Ahmedabad, Gujarat. Read More
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