When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Report on Research Compliance Volume 20, Number 3. February 23, 2023 - The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more
Report on Research Compliance 18, no. 8 (August, 2021) - NIH is continuing to face pushback and questionable actions by institutions grappling with agency-funded “superstar” principal investigators (PIs) who sexually...more
On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more
This Week: Drug pricing remains a focus as CMS rolls out a demonstration project for Part B drugs... The Senate passes The Comprehensive Addiction and Recovery Act (CARA) and Senate Cures legislation moves forward... Senate...more
This Week: The House and Senate were out for Presidents’ Day recess... The Senate to vote on FDA Commissioner nominee Califf after 5:30 today... Medicare Advantage rates announced....more