How Much Does FDA Approval Cost?

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FDA Registration Fees

The fee for FDA registration begins at $250. It is based on the facility’s size and type. For renewals, the fee is $150. Foreign establishments and electronic registration cost $175. Facilities must renew registration in the 5th month after their anniversary to stay registered. After paying the fee, the FDA issues an establishment registration number.

FDA Approval Process

The FDA approval process can take one week to eight months. This depends on whether registration is self-submitted or if a 510(k) or Premarket Approval (PMA) application is filed. A PMA application undergoes the most stringent review. The FDA approves it if the application has enough evidence that the device is safe and effective.

Consult an expert to accurately estimate certification costs and adherence to regulations. The FDA aims primarily to protect the public from harm, but its standards are difficult for some companies.

Drug Approval Costs

The cost to submit a New Drug Application (NDA) is substantial. For 2020, the fee for an NDA requiring clinical data is $2,942,965. Manufacturers must conduct testing and submit their data to the FDA. The agency reviews the data and may approve the drug if benefits outweigh risks. Documents can be uploaded into the Import Trade Auxiliary Communication System (ITACS).

FAQ

How much does it cost to get a drug FDA approved?

  • FDA registration fee: $250
  • Renewals: $150
  • Foreign facilities and electronic registration: $175
  • Registration renewal timeframe: in the 5th month after the facility’s anniversary
  • FDA establishment number issued upon payment

Do you have to pay to get FDA approval?

  • Registration, renewals, and fees are as stated above.
  • Approval depends on self-registration or application type—510(k) or PMA.
  • Timeframe for approval: one week to eight months.
  • A PMA undergoes more extensive review.
  • Expert consultation may be needed to navigate certification costs and regulatory adherence.

New Drug Application (NDA) Fees

  • 2020 fee for an NDA with clinical data: $2,942,965
  • Testing and data submission are required.
  • FDA approval is possible if the benefits of the drug outweigh the risks.
  • Submission of documents through ITACS is part of the process.

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