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HEALTH AND HUMAN SERVICES, DEPARTMENT OF has floated a tender for 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. The project location is USA and the tender is closing on 23 May 2023. The tender notice number is 75F40123R00058, while the TOT Ref Number is 82428581. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : 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
Deadline : 23 May 2023
Other Information
Notice Type : Tender
TOT Ref.No.: 82428581
Document Ref. No. : 75F40123R00058
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Login to see detailsTender Details
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.
Active Contract Opportunity
Notice ID : 75F40123R00058
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office : FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: May 02, 2023 05:05 pm EDT
Original Date Offers Due: May 23, 2023 03:00 pm EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: Jun 07, 2023
Initiative: None
Classification
Original Set Aside:
Product Service Code: B599 - SPECIAL STUDIES/ANALYSIS- OTHER
NAICS Code: 541720 - Research and Development in the Social Sciences and Humanities
Place of Performance: Silver Spring, MD 20903 USA
Documents
Attachment-No.-2--USMCA-Class-Deviation-2020-05.pdf
Attachment-No.-3-Class-Deviation-2020-02-Accelerated-Payments-Small-Business.pdf
Attachment-No.-4--Class-Deviation-2018-01-Whistblower-Protection.pdf
Attachment-No.-5--Past-Performance-Questionnaire-Revised.doc
Attachment-No.-6-IDIQ-SOW.docx
Procurement Documents for USA
Access a comprehensive library of standard procurement documents specific to USA. Here, you'll find all the essential forms, guidelines, and templates required for tender applications and submissions in USA
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