This file provides essential guidance on reserving a National Drug Code (NDC) through CDER. It outlines the benefits, who should reserve, necessary timing, and the process for completing the reservation. Understanding these guidelines ensures compliance and effective product launches.

This manual provides comprehensive guidelines on the NDA classification codes assigned by CDER.

This document provides essential guidelines for completing FDA Form 3938 for Drug Master Files (DMFs). It outlines the necessary steps for various stakeholders involved in the submission process. Use this resource to ensure compliance and streamline your application.

This document provides a detailed job description for the Quality Control Coordinator position at States Manufacturing. It includes job responsibilities, skills, qualifications, and application instructions. Ideal for candidates with experience in operations, engineering, or manufacturing environments.

This file provides comprehensive guidance on the submission of Chemistry, Manufacturing, and Controls (CMC) and Establishment Description information for human blood and blood components. It includes detailed instructions for completing the Form FDA 356h to ensure compliance with FDA regulations. This document is essential for manufacturers seeking licensure for blood and blood components intended for transfusion or further manufacture.

This file provides detailed guidance on ANDA submissions and their content requirements. It serves as a helpful resource for both industry professionals and regulatory personnel. It focuses on ensuring compliance with FDA standards for generics.

This document provides guidance for industry regarding medical product communications that comply with FDA-required labeling. It includes questions and answers to assist stakeholders in navigating these communications effectively. Essential for understanding FDA compliance for medical products.

This file provides comprehensive guidance for the industry regarding solid oral dosage forms. It details the processes of scale-up and postapproval changes, chemistry, manufacturing, and controls. Users will find important information on in vitro dissolution testing and in vivo bioequivalence documentation.

This document provides insights and updates regarding regulatory submissions. It serves as a valuable resource for professionals in the drug evaluation field. Stay informed on recent changes and best practices.

This file contains essential instructions for completing Form FDA 2252. It provides clear guidelines on submission requirements for NDAs, ANDAs, and BLAs. Users will find detailed information regarding application types and report requirements.

This document serves as a comprehensive guide for completing the Investigational New Drug Application (IND), specifically Form FDA 1571. It provides essential information, guidance, and tips for sponsors and investigators, ensuring compliance with FDA regulations. Users will find detailed instructions and important notes to streamline their application process.

This draft guidance document provides essential information regarding the inspection of injectable products for visible particulates. It outlines regulatory frameworks, clinical risks, and quality risk assessment aspects. Professionals involved in drug evaluation will find this guidance crucial for ensuring quality and compliance.