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Medmarc Blog (blog.medmarc.com)

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Health and Human Services (HHS)

GAO Report Highlights FDA Staff Shortages for BiMo Inspections

April 24, 2024

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

March 11, 2024

The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...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

December 27, 2023

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

September 28, 2022

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...

April 27, 2022

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FDA Device Notification Rule Withdrawn

April 20, 2021

The FDA has withdrawn a Jan. 15, 2021, rule by the Department of Health and Human Services that had would have exempted more than 80 medium-risk device types from premarket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

March 30, 2021

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

January 28, 2021

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

November 18, 2020

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

November 02, 2020

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....