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
- Health systems lean toward established partners for AI adoption
- Immigration raids are driving patients back to telehealth and ERs
- Study: Global access to surgery deemed a crisis, leaves 160 million without care
- Large-scale studies link preoperative cognition to delirium risk, reveal its deadly toll after surgery
- Socioeconomic deprivation linked to lower fitness before surgery, UK study finds
- Perioperative medication decisions need individualized risk-benefit approach
- FDA: National IV saline shortage over after years of strained supply
- FDA announces Class 1 recall for Draeger breathing filters
- Hospital CEO departures surge, boards turn to interim leadership
- Study: Attire shapes patient trust, perceptions
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement