United States Government Repurposing References
This presentation provides an overview of the 505(b)(2) regulatory pathway for new drug applications.
This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)).
The public may submit comments on the updated DMF guidance online or in writing.
Submit online comments here.
Written comments can be mailed to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with the document's docket number: FDA-2019-D-3989.
116TH CONGRESS 2D SESSION H. R. 5668 -A Bill to amend the Federal Food, Drug, and Cosmetic Act to modernize the labeling of certain generic drugs, and for other purposes.
FDA (2020)
Get to know the investigational new drug (IND) application. This includes the types, laws and regulations, and emergency use of INDs.
CDER Small Business and Industry Assistance (SBIA) (2019) FDA
Highlight: The innovative regulatory approaches resulting from the 21st Century Cures Act are modernizing new drug development. The use of clinical trials with Master Protocol design is one example of a modern approach to expedite the development of oncology drugs and biologics. Because of the complexity of these trials and the potential regulatory impact, it is important that such trials are well designed and well conducted to ensure patient safety and to obtain quality data that may support drug approval.
Darrow, J.J., Avorn, J., Kesselheim, A.S. (2020) JAMA
Abstract Abbreviated:
Importance US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.
Objective To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018.
FDA (2014)
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more 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. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.