- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
[Final posted 6/16/2020]
This guidance (Guidance 1) is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents3 that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data4 and other relevant information from patients and caregivers for medical product5 development and regulatory decision making.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1893.