Drug Master Files

-

      

Drug Master Files


A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, human drugs.


The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder.


An Export Application, a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or an Investigational New Drug Application (IND) may be supported by the data in the DMF. modifications and additions to any of these.”


DMFs: 

  • are often made so that material can be referenced by parties other than the DMF holder without revealing the file's contents to them.
  •  do not substitute for other applications, including BLAs, ANDAs, INDs, or NDAs.
  • are neither specifically accepted or rejected by the FDA




Types of DMFs



Status of DMFs


A”- Active; this means that the DMF was found acceptable for filing, administratively, and has not been closed.

“C”- Complete; this means that the DMF has undergone a successful Completeness Assessment 

“I”- Inactive; this means a DMF that has been closed, either by the holder or by the FDA.

“P”- DMF Pending Administrative Filing review

N”- Not an assigned number; this can occur for a number of reasons, e.g., the holder withdrew the DMF during the administrative review or the DMF was transferred to another Center.
 



Comments

Post a Comment

Popular posts from this blog

checklist for registration of IND as per ICH CTD format

-
 INTRODUCTION:  ABOUT ICH: “International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use”. This project brings together regulatory authorities of Europe, Japan & US, to discuss scientific & technical aspects of pharmaceutical product registration. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed, and registered and maintained in the most resource-efficient manner while meeting high standards.1 ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective, and high-quality medicines are developed and registered efficiently. ABOUT CTD: CTD - Common Technical Document3 The agreement to assemble all the Quality, Safety, and Efficacy information in a common format called CTD has revolution...
Read more

REGULATORY AUTHORITIES OF DIFFERENT COUNTRIES

-
REGULATORY AUTHORITIES OF DIFFERENT COUNTRIES Various regulatory authorities in major developed and developing nations around the world, as well as the scope and issues these organizations face in delivering safe and effective healthcare goods. USA   Food and Drug Administration (FDA) Europe European Medicines Agency (EMEA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Sweden Medical Products Agency (MPA) Netherlands Medicines Evaluation Board Ireland Irish Medicines Board Italy Italian Pharmaceutical Agency Denmark Danish Medicines Agency Australia  Therapeutic Goods Administration (TGA)  Japan Ministry of Health, Labor & Welfare(MHLW) India   Central Drug Standard Control Organization (CDSCO) Canada   Health Canada Costa Rica Ministry of Health Nigeria  National Agency for Food and Drug Administration and Control (NAFDAC) Ukraine   Ministry of Health Singapore Centre for Pharmaceutical Administrati...
Read more

New Drug Application(NDA)

-
Image
  New Drug Application It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug. In simple words, ―It is an application for the approval of Generic Drugs. A New Drug Application (NDA) is a comprehensive submission to the U.S. Food and Drug Administration (FDA) by a drug sponsor seeking approval to market a new drug in the United States. The NDA provides detailed information to the FDA to evaluate the safety, efficacy, labeling, and manufacturing standards of the new drug. It includes data from laboratory and animal preclinical studies as well as human clinical trials (Phase 1-4). The FDA reviews the NDA within 60 days of submission and issues one of three action letters: Approval Letter, Approvable Letter, or Not Approvable Letter The NDA's goals are to offer adequate material for FDA reviewers to make the following essential decisions: Whether the medicine is safe and effective in its intended application(s), and wh...
Read more