Page 2 - Drug Admin News Today

Center for Biologics Evaluation and Research is on a roll in enforcing HCT/P regulations, this enforcement trend indicates that FDA is keeping a close eye on the promotion of such products and making sure they are properly classified and undergo appropriate premarket review.

Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed...

Reagan-Udall Report of Center for Tobacco Products, notes that CTP’s role is not only protection via regulation but also via educating the public, especially young people. CTP is initiating the development of a comprehensive 5-year strategic plan.

Employer-sponsored health plan coverage of surgical and medication abortion and related services, including travel benefits, has been the subject of extensive litigation since the US Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization.

Medication abortions using mifepristone and misoprostol now account for more than half of all abortions performed in the United States today...

Ransomware is the “fastest growing malware threat.” In 2022, attacks in health care increased by 328%, a study found. Another recent study reports that from 2016 to 2021, the “annual...

Medication abortions using mifepristone and misoprostol now account for more than half of all abortions performed in the United States today. In the post-Dobbs era, medication abortion...

On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of...