(AGENPARL) - Roma, 29 Giugno 2022(AGENPARL) – SILVER SPRING mer 29 giugno 2022
Submit Comments by 09/29/2022
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
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-N-2455
- Docket Number:
- FDA-2018-N-2455
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. When finalized, Guidance 3 will represent the current thinking of CDER, CBER, and CDRH on this topic. The topics that each guidance document addresses are described below.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-selecting-developing-or-modifying-fit-purpose-clinical-outcome
