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. Source: Drug…

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…

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. Source: Drug Industry Daily

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…

In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Source: Drug Industry Daily

The Chinese FDA is proposing to relax restrictions on imported drugs by no longer requiring that foreign drugs be approved abroad, or in late-stage clinical trials, before an international multi-center…

Two foreign manufacturing facilities have landed FDA warning letters over data integrity and quality management deficiencies. Source: Drug Industry Daily

Three senior FDA officials urged the Senate HELP Committee hearing Tuesday to move forward on user fees for drugs and biologics or risk funding problems at the agency. Source: Drug…

FDA inspectors observed several violations at a VistaPharm facility in Largo, Fla., including contaminated water used in manufacturing and batches of drugs that were not tested for impurities. Source: Drug…

The FDA granted over 99 percent of requests for expanded access in fiscal 2016, including 100 percent of emergency IND applications and protocols. Source: Drug Industry Daily