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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
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
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 trial can be started in China to seek an approval. Read More
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. Read More