Drug Development Documents

This file provides essential information regarding Forms FDA 3542a and 3542, including their purpose and instructions for use. It is vital for individuals submitting patent information to the FDA. Detailed guidance on how to fill out these forms is also included.

This document provides detailed instructions for completing the Traditional 510(k) Acceptance Checklist. It includes preliminary questions and organizational elements necessary for FDA submissions. Users must follow the outlined guidance to ensure their submissions are administratively complete.

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.

This file provides comprehensive guidance on using Adobe Sign for electronic consent in clinical trials. It includes step-by-step instructions, best practices, and essential tips for navigating the consent process. Ideal for researchers and clinical trial coordinators at DFCI and similar institutions.

This Clinical Trial Application Form (CTA) provides essential guidelines for applicants submitting their clinical trial protocols. It covers all necessary fields, including investigational product details and required documentation. Ensure compliance with the submission requirements to facilitate a smooth application process.

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.

This document provides essential guidance for sponsors, clinical investigators, and IRBs on the FDA’s regulations and procedures. It outlines frequently asked questions and offers clarity on Form FDA 1572 requirements. Suitable for those involved in clinical research, it's an important resource for compliant study management.

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.

This file contains the details regarding the FDA application number 022573 for norethindrone and ethinyl estradiol chewable tablets. It lists officers involved in the approval decision and includes instructions for form submission. Users will find important dates and guidelines pertinent to this application.

This file provides detailed instructions for completing the FDA Recall Audit Check Report. It includes information on recall details, program data, audit accounts, and consignee data. Useful for those involved in managing FDA recalls.

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.

This file provides a comprehensive clinical trial application form for requesting authorization from competent authorities. It includes critical sections for clinical trials on medicinal products for human use. Designed for sponsors, it guides users through necessary information for submission.