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SAMDAILY.US - ISSUE OF MAY 04, 2023 SAM #7828
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
5/2/2023 2:05:23 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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/b72c8eac422a484d85f3e659094f52dc/view)
 
Place of Performance
Address: Silver Spring, MD 20903, USA
Zip Code: 20903
Country: USA
 
Record
SN06668462-F 20230504/230502230112 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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