Medmarc Blog (blog.medmarc.com)
Health and Human Services (HHS)
GAO Report Highlights FDA Staff Shortages for BiMo Inspections
The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such...
FDA Proposes New Formats for Informed Consent
The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...
White House Announces Women’s Health Research Program
The White House has announced a program titled the Initiative on Women’s Health Research, which among other things will amplify ongoing programs at the FDA designed to improve health outcomes for...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
AdvaMed Revises its Code of Ethicsitle Here...
The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...
FDA Device Notification Rule Withdrawn
The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket notification...
HHS Suspends SUNSET Rule
The Department of Health and Human Services posted notice of suspension of the Securing Updated and Necessary Evaluations Timely (SUNSET) rule, which would have required review of HHS agency...
HHS Posts Civil Enforcement, Regulatory Review Mandates
The administrative levers at the U.S. Department of Health and Human Services will change hands shortly, but the current administration has taken two actions that each could have a significant...
HHS Proposes Decennial Review of Regulations
The U.S. Department of Health and Human Services posted a notice of proposed rulemaking requiring HHS agencies to periodically assess their regulations to determine whether a regulation is...
HHS Announces Delayed HIT Compliance Deadlines
The Department of Health and Human Services has responded to concerns about compliance dates for healthcare IT with an interim final rule that relaxes those deadlines by nearly half a year....