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The FDA has handed warning letters to three supplement makers for GMP issues such as improper storage and undeclared ingredients, as well as implied marketing for pharmaceutical indications. Read More
Comments to the European Commission on proposed changes to orphan drug policy show much agreement on the need for change, but little agreement on how to make those changes. Read More
Sponsors that fail to address all pediatric age groups or indications in their initial pediatric study plans would have 30 days to address any deficiencies and submit a new plan, FDA says. Read More
Amarin Pharmaceuticals will be able to promote its cholesterol drug Vascepa for off-label uses after resolving differences with the FDA in a free speech case involving off-label promotion of the capsules. Read More
Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More