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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
The FDA has released final guidance on assessing the risks and benefits of investigational device exemption applications for human clinical studies. Read More
Last year’s 21st Century Cures Act directed federal agencies to pursue an international pediatric clinical trials network, and to engage with foreign regulators alongside attempts to align international guidance. Read More