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GDF REAUTHORIZATION PERFORMANCE GOALS AND PROGRAM ENHANCEMENTS FISCAL YEARS 20182022 I. SUBMISSION REVIEW PERFORMANCE GOALS A. Original Andes and Amendments B. Pass and PAS Amendments C. Unsolicited
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Review the instructions provided by the FDA for filling out the GDUFA commitment letter.
02
Fill in the required information accurately, including your company name, address, and contact details.
03
Provide details regarding the specific drug product for which you are submitting the commitment letter.
04
Ensure that you include all necessary supporting documentation, such as the drug product's application number.
05
Include any additional information or documents that may be requested by the FDA.
06
Review the completed commitment letter to ensure all information is accurate and complete.
07
Submit the filled-out GDUFA commitment letter to the FDA by the specified deadline.

Who needs gdufa commitment letter?

01
Pharmaceutical companies that wish to engage in the manufacturing or distribution of generic drugs in the United States need a GDUFA commitment letter.
02
Contract manufacturing organizations (CMOs) that produce generic drugs on behalf of pharmaceutical companies also require a GDUFA commitment letter.
03
Any company seeking approval for a generic drug from the FDA is required to submit a GDUFA commitment letter.
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The GDUFA commitment letter is a document that outlines a company's pledge to comply with the goals and requirements of the Generic Drug User Fee Amendments.
Manufacturers of generic drug products are required to file the GDUFA commitment letter.
The GDUFA commitment letter can be filled out online through the FDA's electronic submission portal.
The purpose of the GDUFA commitment letter is to ensure that manufacturers of generic drug products comply with the regulations and requirements set forth in the Generic Drug User Fee Amendments.
The GDUFA commitment letter must include information such as the company's name, contact information, and a list of generic drug products being manufactured.
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