July 25, 2019
FDA issues final guidance for drug-device combo products
Editor's Note
The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics.
The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.
Free Daily News
- Suicide Prevention Month: Hospitals prepare for new The Joint Commission suicide prevention goal, effective 2026
- Survey: Perioperative leaders adapt to supply strain, staffing pressure, ASC growth
- Gait retraining eases knee osteoarthritis pain as effectively as medication, can delay knee surgery
- OR leaders must sharpen questions, partnerships as AI reshapes perioperative care
- npj Digital Surgery opens call for research on AI, robotics in the OR
- AI in the OR can sharpen skills, but humans make the lessons stick
- Endoscopy case highlights risks of complex patients in ASCs
- Robotics and AI are redefining precision in cataract surgery
- CMS plan to phase out inpatient only list sparks debate over safety for vulnerable patients
- ACS issues new best practices for managing genitourinary trauma
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement