Drug Development Documents

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Drug Testing

MMCAP Drug Testing Products and Services Contracts

This file outlines the drug testing products and services offered by MMCAP for state agencies and political subdivisions. It details vendor information, ordering instructions, and contact details. Ideal for facilities looking to procure drug testing services efficiently.

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FDA Regulations

Guidance on User Fee Waivers and Refunds for Drugs

This document provides comprehensive guidance on user fee waivers, reductions, and refunds applicable to drug and biological products. It serves as a valuable resource for industry professionals seeking to understand financial considerations and processes related to user fees. Users will find detailed insights on submissions and exemptions outlined by the FDA.

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Clinical Trials

Instructions for Completing Form FDA 1572

This file provides instructions for filling out Form FDA 1572, the Statement of Investigator. It contains detailed guidance for investigators in clinical trials. Essential information for ensuring compliance with FDA requirements is also included.

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FDA Regulations

MDUFMA User Fees Cover Sheet Instructions

The MDUFMA User Fees Cover Sheet is required for Medical Device Application Submission. It includes details on registration and payment processes. Follow this guide to complete and submit your form correctly.