Safe Medication Use Tender, USA - 125994689

Procurement Summary

Country: USA

Summary: Safe Medication Use

Deadline: 18 Sep 2025

Other Information

Notice Type: Tender

TOT Ref.No.: 125994689

Document Ref. No.: 75F40125Q00401

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

Description

Background

The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) is interested in obtaining products, services, and access to medication error[1] data collected from across the United States to inform regulatory and mission critical surveillance activities.

FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.[2], [3], [4] As the FDA continues assessing adverse events associated with the use of drug products in the postmarketing setting, FDA seeks to enhance data coverage through available products, services, and access to medication error data associated with FDA regulated drug products that is gathered nationwide from healthcare providers, consumers, patient safety organizations, published literature, and other sources of safety information.

Objectives

FDA-s objective is to acquire:

Medication error case reports collected from across the U.S. population (including pediatrics and adults) throughout the medication use process[5] with sufficient granularity to understand the type of error, where the error originated, specific product(s) involved in the error, causes or contributing factors for the error, actions taken or recommended to prevent the error from occurring, adverse events and outcomes associated with the error. Unlimited, multi-user access to medication error data from an existing web-based analytics platform[6] that contains at least 5 years of medication error case reports from across the United States to support surveillance activities for identifying and tracking medication error safety related issues.

Medication error data to inform appropriate responses to ...
Active Contract Opportunity
Notice ID : 75F40125Q00401
Related Notice : FDA-RFI-126495
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA CENTER FOR DRUG EVALUATION AND RESEARCH
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: Sep 09, 2025 07:15 am EDT
Original Date Offers Due: Sep 18, 2025 11:00 am EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: Oct 03, 2025
Initiative: None

Classification
Original Set Aside: No Set aside used
Product Service Code: 7A21 - IT AND TELECOM - BUSINESS APPLICATION SOFTWARE (PERPETUAL LICENSE SOFTWARE)
NAICS Code: 541990 - All Other Professional, Scientific, and Technical Services

Place of Performance: Silver Spring, MD 20903 USA

Documents

 Tender Notice

Att-B-Records-management-training.pdf

Att-D-FDA-Form-3398.pdf

SOL_RFQ-75F40125Q00401-SafeMedUse.docx

Att-A-Records-management-cert.pdf

Att-F-Data-Disclosure-Clearance-Form.docx

Att-E-Data-Disclosure-Clearance-Procedures.docx

Att-C-Pricing-Worksheet.xlsx