Last week, the U.S. Department of Health and Human Services ("HHS") announced that FDA intends to update its regulations governing clinical studies of new drugs. More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the "Code" or "CFR"). In its announcement, HHS stated that the revisions will be focused on defining and clarifying "the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements." The ...
Blog Editors
Recent Updates
- Breaking Down the Legal Challenges Surrounding State Licensure Restrictions for Telehealth Providers
- Interested in Opening a Medical Spa? Here’s What You Need to Know
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams