What does DMF mean in US GOVERNMENT
DMF stands for Drug Master File. It is a document that contains information about a drug product, its ingredients and its manufacturing process. The document is kept on file with the US Food and Drug Administration (FDA). The purpose of this document is to ensure that regulated products are safe and effective.
DMF meaning in US Government in Governmental
DMF mostly used in an acronym US Government in Category Governmental that means drug master file
Shorthand: DMF,
Full Form: drug master file
For more information of "drug master file", see the section below.
Essential Questions and Answers on drug master file in "GOVERNMENTAL»USGOV"
What is the purpose of a DMF?
The purpose of a DMF is to provide information to the FDA about a drug product, its ingredients and its manufacturing process so that it can be reviewed for safety and efficacy.
Who can submit a DMF?
A DMF can be submitted by any company who manufactures or distributes any type of regulated product within the US, such as drugs, biologics, and medical devices.
How long does it take for the FDA to review a DMF?
The amount of time it takes for the FDA to review a DMF varies depending on the complexity of the submission. Generally speaking, it can take anywhere from 4-12 weeks for an initial review before allowing access to the facility where the product will be manufactured or distributed.
Is there an expiration date associated with a DMF?
Yes. Depending on the type of submission, there is usually an annual expiration date associated with each DMF. Companies must file an updated version with updates prior to this expiration date in order for their products remain approved by the FDA.
What happens if a company fails to submit an updated version before expiration?
If a company fails to submit an updated version before expiration, then their products may become unapproved by the FDA which could lead to serious consequences including potential legal action.
Final Words:
A Drug Master File (DMF) provides important information about regulated products like drugs, biologics and medical devices to ensure their safety and efficacy in accordance with US laws and regulations set forth by the FDA. Companies must remember to update their submissions prior to any given expiration date in order keep their products approved by the FDA.
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