FDA Drug Application Costs Increase Starting October

The FDA has declared that by 2025, the expense of filing a medicine utilising clinical data would increase to over $4.3 million, an increase of over $300,000. A submission that doesn’t need clinical data will cost less than $2.2 million, whereas filing for authorisation with clinical data will charge a sponsor $4.3 million.

Comparing the expenses to ten years ago, they have almost doubled. Applications needing clinical data cost $2.3 million in 2015, while those that did not cost $1.2 million.

The raised costs will take effect on October 1, 2024, and they will last until September 30, 2025.

The agency set these prices last year, and they have already risen significantly. For example, a medicine that needs clinical data is slated to cost $3.2 million, while a treatment that does not require data is estimated to cost about $1.6 million. In 2023, the cost of the prescription medication program charge was $393,933.