See What’s Possible in Life Sciences Packaging @ PACK EXPO International
2,600 exhibitors. 150+ free educational sessions. See packaging solutions for life sciences & more @ PACK EXPO International, Oct 18-21 in Chicago
REGISTER NOW & SAVE

Create a free Healthcare Packaging account to continue reading

FDA issues guidance to streamline medical device clinical trials

Bio-Medicine.org eports, "U.S. Food and Drug Administration issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies."

The article quotes FDA Commissioner Margaret A. Hamburg, M.D., as saying the guidance is “consistent with the FDA's commitment to streamline clinical trials.”

On a related note, the agency notes that due to its redesigned Web site, the Good Clinical Practice Program has moved. Further details are available…

More clinical trials information is available from the following sources:

• Parenteral Drug Assn.'s Clinical Trial Materials Interest Group.

• Intl. Society for Pharmaceutical Engineering's 45-minute Webinar, “Investigational Products: Tackling Packaging Challenges for Clinical Trials.” Cost: $49 for members; $149 for nonmembers.

• FDA's Compliance & Enforcement information links.

--Jim Butschli, Editor, Healthcare Packaging magazine
See What’s Possible in Life Sciences Packaging at PACK EXPO International
Explore new machinery & materials from 2,600 exhibitors. Gain insights from 150+ free educational sessions. Find solutions to tackle the toughest challenges—for life sciences & beyond—at North America’s largest packaging & processing event.
REGISTER NOW & SAVE
See What’s Possible in Life Sciences Packaging at PACK EXPO International
Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Fresh from the show floor: pharma packaging innovations for 2026