Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).
What Clinical Investigations are Affected?
Importantly, the only clinical investigations affected by the Proposed Rule are those that are FDA-regulated and ...
Blog Editors
Recent Updates
- Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases
- Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program
- Federal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?
- HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived