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The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 11 products for new marketing authorizations this month, including five orphan drugs. Read More
The HHS arm that oversees the discounted drug pricing program has made some improvements to its operations since 2011 but it lacks regulatory authority to make other needed changes. Read More
The court made the ruling in response to a challenge by Actavis Pharma, Endo Pharmaceuticals, Janssen Pharmaceuticals, Purdue Pharma and Teva Pharmaceuticals. Read More
The agency will use marketing materials about a fictional weight loss drugs and migraine medications to see who reads and retains risk information better. Read More
Drugmaker Tubilux Pharma manufactured products in conditions that risked contamination and failed to properly test its products before release, according to the FDA. Read More
A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More
Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable drugs. Read More
PhRMA and AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical products, saying that the rule’s altered “intended use” definition is overbroad in its restriction of communications. Read More
The Senate Appropriations Committee unanimously approved a bill on Thursday that would provide a total of $5.2 billion for the FDA in fiscal 2018. Read More