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: Longer shifts, understaffing increase nurse sickness absence
- Power loss risks prompt FDA Class 1 recall designation for heart pump accessories
- Therapy dogs ease nurse burnout, boost morale
- Personalized perioperative pain management reduces opioid use
- Study: Colibactin-producing gut bacteria fuel colorectal cancer surge
- Augmented reality gains FDA nod, 10k-case milestone in orthopedics, strides in outpatient surgery
- Smart patient selection anchors DISC’s high-acuity spine ASC model
- Postop opioid prescriptions following outpatient surgery see steep, sustained fall
- Study: Bariatric surgery offers cost, survival benefits for cirrhosis patients
- AI monitoring, remote surgery advance
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement