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
- Study: ERAS protocol reduces opioid use after cardiac surgery
- Study: Prehabilitation reduces surgical complications, speeds recovery
- Commentary: Studies show how surgeon decisions follow the money
- Proposed HIPAA updates would improve cybersecurity, increase costs for healthcare providers
- Study: EMR data can enhance hand hygiene compliance, infection prevention
- Study: Machine learning model improves perioperative pain assessment
- Call for improved suicide risk screening in ASCs aims to strengthen safety protocols
- Study: Perioperative pregabalin reduces risk of kidney decline compared to gabapentin
- Medical school diversity declines after Supreme Court ruling
- Surgeons risk losing ground as transcatheter tricuspid valve interventions rise
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement