SAMDaily.us | PRESOL | B | Comparative Use Human Factors Studies to Assess the Impact of Differences Between the User Interface of a Generic Drug-Device Combination Product and its Reference Listed Drug

SAMDAILY.US - ISSUE OF MAY 20, 2023 SAM #7844
SOLICITATION NOTICE

B -- Comparative Use Human Factors Studies to Assess the Impact of Differences Between the User Interface of a Generic Drug-Device Combination Product and its Reference Listed Drug

Notice Date: 5/18/2023 12:25:56 PM
Notice Type: Combined Synopsis/Solicitation
NAICS: 541720 — Research and Development in the Social Sciences and Humanities
Contracting Office: FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
ZIP Code: 20705
Solicitation Number: 75F40123R00058
Response Due: 5/23/2023 12:00:00 PM
Archive Date: 06/07/2023
Point of Contact: HILDA ARYEH
E-Mail Address: hilda.aryeh@fda.hhs.gov
(hilda.aryeh@fda.hhs.gov)
Description: The primary objective of this project is to conduct multiple CUHF studies of complex drug-device combination products in relevant populations (e.g., patients and/or caregivers and/or health care providers) to assess the impact of �other� design differences between the user interfaces of an RLD and existing or potential generics referencing the RLD. See Attachment for Detailed RFP. See attachment for Contractor's questions and Government responses.
Web Link: SAM.gov Permalink
(https://sam.gov/opp/99348bac62bb426bb9216450271b9e33/view)
Place of Performance: Address: Silver Spring, MD 20903, USA; Zip Code: 20903; Country: USA
Record: SN06686890-F 20230520/230519211954 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

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