Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program: Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 20, 2023
June 20, 2023
b901f295-6476-4a9d-8803-b6fedae71771
Related Documents
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJanuary 29, 2026Center for Devices and Radiological Health
Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff
Guidance DocumentJune 22, 2007Center for Devices and Radiological Health
Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 14, 2023Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.