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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
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
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Read More
Robert Califf was sworn in as the new commissioner of the FDA Feb. 25 after the Senate confirmed him on Feb. 24 in a roll call vote of 89 to 4. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
Drugmakers producing hormones should consult with the FDA before seeking to opt out of an environmental assessment because of the impact of those drugs on the water supply. Read More