Drug Development Documents

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 document provides comprehensive details about D-Lysergic Acid Diethylamide (LSD), including its uses, effects, and user statistics. It is crucial for anyone looking to understand this potent hallucinogen. The file also covers its illicit uses and clinical observations.

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 file contains a review memorandum for the revised label and labeling of Orfadin (nitisinone). It details the evaluation conducted by DMEPA regarding medication error prevention. This document is essential for understanding the labeling requirements and compliance standards.

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.

This file provides important guidelines for submitting export certificate requests to the FDA. It outlines the necessary information and the process for obtaining certificates for various products. Ideal for manufacturers and distributors looking for compliance with FDA regulations.

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 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 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.

The FDA 3674 form provides essential certifications required for submitting drug, biological product, and device applications. This guidance helps sponsors, researchers, and investigations meet compliance standards. It's crucial for ensuring that necessary certifications accompany relevant applications.