NorthWest Biotherapeutics Inc (NWBO)

[Steady_T]

FY 2023 and FY 2024 User Fee Rates 
 Fee Category	Fee Rates for FY 2023	Fee Rates for FY 2024 
 Application	 	  
      Requiring clinical data	$3,242,026	$4,048,695 
      Not requiring clinical data	$1,621,013	$2,024,348 
 Program	$393,933	$416,734

Are there any waivers of user fees?

Under section 736(d) of the FD&C Act, a waiver may be granted for one or more user fees where:

A waiver or reduction is necessary to protect the public health;
The assessment of the user fee would present a significant barrier to innovation due to limited resources or other circumstances; or
The applicant involved is a small business submitting its first human drug application to FDA for review.
To be granted a waiver, the human drug applicant must submit a written request for the waiver. Applicants may submit written requests (for both CDER and CBER products) via email to [e-mail].

Is there a user fee for orphan drugs?
Designated Orphan Drug or Indication: An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.Dec 14, 2023