Oncology drug products used with certain in vitro diagnostic tests: pilot program : guidance for industry, clinical laboratories, and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, June 20, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Antineoplastic Agents Drug Industry Government Regulation In Vitro Techniques United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- FDA is issuing this guidance to announce and describe FDA’s voluntary pilot program for certain Center for Drug Evaluation and Research (CDER)-regulated oncology drug products used with certain in vitro diagnostic tests, as described in the scope below. Given the public health importance of such in vitro diagnostic tests for determining a patient’s cancer treatment, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (7 pages))
- NLM Unique ID:
- 9918662583006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662583006676