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The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing Wednesday. Read More
Sanofi and Regeneron filed a complaint seeking a declaratory judgment that their eczema drug Dupixent, which is pending an FDA approval, does not infringe an Amgen patent on an unsuccessful asthma candidate. Read More
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Read More
The FDA will have to staff up and hire new kinds of scientists to fully implement the provisions of the 21st Century Cures Act and the next generation of user fee agreements, according to FDA leadership. Read More
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More