Skip to content
March 26, 2023
Blogolu

Blogolu

A Directory of Wonderful Things

Primary Menu Blogolu

Blogolu

  • Health and Fitness
  • Newsbeat
  • Compliance
  • Business
  • Food
  • Photography
  • WordPress
  • World
  • Questions & Answer

What is a Type IV Drug Master File (DMF) and what information is contained in this type of DMF?

907 viewsOctober 10, 2022DrugsPharmaceutical
0
Sam Smith11.38K December 15, 2020 0 Comments

1 Answer

  • Active
  • Voted
  • Newest
  • Oldest
0
Blogolu28.38K Posted December 15, 2020 0 Comments

A Type IV DMF is a file within the FDA which can be used by excipient manufacturers to submit confidential formulation, safety and manufacturing information about the excipient that may be needed by the agency in reviewing a new drug application (NDA) for a drug product containing that excipient. These files are only referenced by FDA as part of a specific NDA review and are not authorized or approved by FDA.

Users of the excipient are required to submit a DMF reference letter from the excipient manufacturer to the FDA as part of their NDA to allow FDA authority to access the DMF for their application. An FDA guidance document exists which describes what types of information are required in a Type IV DMF and the format which should be used. Not a lot of detailed information is required. Mostly, it is up to the excipient manufacturer to determine what types of information they want to include in the DMF. Further, there is no requirement that an excipient have a DMF. This determination is entirely up to the manufacturer of the excipient, depending on the nature of any confidential information which may exist.

Register or Login

Other Categories

  • Art and Design
  • Blogolu
  • Book and Writing
  • Business
  • Compliance
  • Cricket
  • Entertainment
  • Fashion and Beauty
  • FDA
  • Finance
  • Food
  • Graphic Design
  • Health and Fitness
  • Home Services
  • ISO
  • ISO 2768
  • Lifestyle
  • Newsbeat
  • OSHA
  • Photography
  • Science
  • Smart Phones
  • Stories
  • Tech
  • Travel
  • USA
  • WordPress
  • World
  • Latest
  • Popular
  • Trending
    • WordPress

    How to Create Inquiry Form on WordPress Website

    2 months ago Blogolu
    • Compliance

    Anti-Corruption Laws – FCPA & UK Bribery Act

    5 months ago Anubha Srivastava
    • Compliance

    Business Ethics: Importance & Practices

    5 months ago Anubha Srivastava
    • Compliance

    Food and Drug Administration (FDA) of the United States- Import Requirements

    5 months ago Anubha Srivastava
    • Compliance

    Travel And Expenses (T&E): IRS Compliance and Identify & Preventing Fraud

    5 months ago Anubha Srivastava
    • WordPress

    How to Create Inquiry Form on WordPress Website

    2 months ago Blogolu
    • Health and Fitness
    • Newsbeat
    • Stories

    America’s abortion ban will effect women everywhere

    8 months ago Sam Smith
    • Health and Fitness

    Everything you need to know about BEDOYECTA TRI (HYDROXOCOBALAMIN, VITAMIN B1, VITAMIN B6)

    8 months ago Sam Smith
    • Book and Writing

    How to Write a Book – Beginners Guide

    8 months ago Sam Smith
    • Photography

    Tips for Capturing the Night Sky with Your Smartphone

    8 months ago Sam Smith
    • WordPress

    How to Create Inquiry Form on WordPress Website

    2 months ago Blogolu
    • Compliance

    Anti-Corruption Laws – FCPA & UK Bribery Act

    5 months ago Anubha Srivastava
    • Compliance

    Business Ethics: Importance & Practices

    5 months ago Anubha Srivastava
    • Compliance

    Food and Drug Administration (FDA) of the United States- Import Requirements

    5 months ago Anubha Srivastava
    • Compliance

    Travel And Expenses (T&E): IRS Compliance and Identify & Preventing Fraud

    5 months ago Anubha Srivastava

You may have missed

  • WordPress

How to Create Inquiry Form on WordPress Website

2 months ago Blogolu
  • Compliance

Anti-Corruption Laws – FCPA & UK Bribery Act

5 months ago Anubha Srivastava
  • Compliance

Business Ethics: Importance & Practices

5 months ago Anubha Srivastava
  • Compliance

Food and Drug Administration (FDA) of the United States- Import Requirements

5 months ago Anubha Srivastava
  • Compliance

Travel And Expenses (T&E): IRS Compliance and Identify & Preventing Fraud

5 months ago Anubha Srivastava

Blogolu

Blogolu is a bloging platform designed not only to inform readers, but to give complete information visibility of the topic and, ultimately, to push readers towards researched content of products, services, place or a thing. Blogolu blog post can vary in length but is usually design to provide complete information on any topic.

Trending Topics

Art and Design Blogolu Book and Writing Business Compliance Cricket Entertainment Fashion and Beauty FDA Finance Food Graphic Design Health and Fitness Home Services ISO ISO 2768 Lifestyle Newsbeat OSHA Photography Science Smart Phones Stories Tech Travel USA WordPress World
  • Facebook
  • LinkedIn
  • Twitter
  • Instagram
  • YouTube
Blogolu © All rights reserved |