Posts tagged Shinal v. Toms.
Blogs
5 minute read
The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated significant changes to informed consent laws. As a result of these changes, sponsors of research ("Sponsors"), institutions conducting research ("Institutions"), and the institutional review boards ("IRBs") approving research will need to review policies and practices involving informed consent. As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by ...
Blog Editors
Recent Updates
- Federal Embryo Adoption Program Raises Potential Legal Questions for Reproductive Health
- Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers
- DOJ’s Second National Health Care Fraud Takedown of the Second Trump Administration Heavily Targets Medicaid Fraud
- FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements
- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing