The FDA cited multiple problems with labeling claims at a Phoenix manufacturer that specializes in colostrum, the milk produced by maternal mammals immediately after giving birth. Source: Drug Industry Daily
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Source: Drug Industry Daily
The FDA approved Adamas Pharmaceuticals’ Gocovri (amantadine) for the treatment of dyskinesia in Parkinson’s disease patients receiving levodopa therapy, making it the first drug to be approved for that condition.…
Consumers find short lists of drug risks in broadcast advertising easier to recall, according to a new study by researchers at the FDA and RTI International’s Center for Communication Science.…
The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Source: Drug Industry Daily
A United States appeals court revived an antitrust lawsuit against four drugmakers alleging that they hamstrung generics for Lipitor and Effexor XR. Source: Drug Industry Daily
Democrats in the Michigan Legislature outlined their plan for state review of large drug price hikes Aug. 21 hoping to push their state into similar efforts in Ohio and California.…
The FDA warned a manufacturer of skin-care drug products in The Philippines for significant GMP violations. Source: Drug Industry Daily
In a citizen petition, the Wilson Disease Association asked the FDA to approve two ANDAs from Kadmon Holdings for generic trientine. Source: Drug Industry Daily
U.S. Bioservices will pay $13.4 million to settle a lawsuit concerning allegations the company illegally billed federal and state insurers for prescriptions for Novartis AG’s Exjade in exchange for referrals…