Keyword: 21st Century Cures Act
The framework builds on the 21st Century Cures Act by setting criteria for the RMAT designation and outlining the benefits of the regulatory status.
Parexel has set up a team committed to providing real-world data insights.
The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up plans to speed up the drug regulation process.
Participants of clinical trials organized by Parexel can now visit trial sites less often. Through a new program, the CRO is offering to collect study subject data remotely using wearables.
At almost 1,000 pages, the 21st Century Cures Act is quite literally a weighty piece of legislation that will have far-reaching consequences for pharma in 2017 and beyond.
The European Medicines Agency recently held a workshop with stakeholders about adaptive pathways, which also allows more real-world data into drug approvals.
The 21st Century Cures Act has already passed both section of the Congress, but several proposed changes to the clinical research and drug approval process still await detailed guidance from regulatory authorities.