Trial Design, Treatment Options Spotlighted in Xylazine Conference
Longer observation periods following treatment and safety considerations for chronic and frequent users are among the many research issues about xylazine-laced fentanyl that need addressing, Rachel Wightman, MD, said at a meeting on mitigating risks from human xylazine exposure sponsored by the Reagan-Udall Foundation. “I take care of patients that are using fentanyl 10 plus […]
This Product Claims To Ease Period Pain. Here’s What Doctors Think.
Charday Penn via Getty Images Experts say there are a few considerations you should make before trusting any new period pain treatment. If you’re one of the estimated 80% of women who experience painful periods every month, a condition known as dysmenorrhea, there’s a good chance you’ve tried something, anything, to get some much-needed relief. […]
Children in Clinical Trials: FDA’s Proposed Rules of Engagement
FDA issued draft guidance on ethical considerations and special safeguards for having children participate in clinical trials. The new statement addresses how to protect children in clinical investigations for drugs, biological products, and medical devices. Some of the fundamental concepts that the new guidance included for consideration by industry, sponsors, and institutional review boards (IRBs) […]