FDA Regulations Documents

This document provides comprehensive guidelines for the FDA's Premarket Approval Application (PMA) program and relevant postapproval requirements. Users will find instructions about submitting reports, amendments, and periodic updates. Essential for regulatory compliance and understanding the responsibilities post-approval.

This file contains the FDA's written request regarding pediatric studies for sofosbuvir. It outlines the requirements for study submissions. The document also includes essential information and guidance for the involved parties.

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.

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.

This document serves as a comprehensive guide for the Statement of Investigator (Form FDA 1572). It details the requirements for clinical investigators in research studies. Ideal for sponsors, clinical investigators, and IRBs seeking clarity on FDA guidelines.

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 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 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 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 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 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.