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GDF II: PostComplete Response Letter Meeting Requests Heidi Lee, Harm. D. Immediate Office Project Manager Office of Regulatory Operations, Office of Generic DrugsPurpose To provide an overview of
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To fill out the GDUFA II post-complete response, follow these steps:
02
Review the guidance documents provided by the FDA to understand the requirements for the post-complete response.
03
Collect all the necessary information and data required for the response.
04
Prepare a cover letter that provides a brief overview of the post-complete response submission.
05
Organize the response in a logical and systematic manner, dividing it into sections as per the FDA's instructions.
06
Clearly address each point raised by the FDA in the original complete response letter.
07
Provide supporting documentation and evidence, such as updated data, studies, or revised procedures.
08
Include a detailed explanation or justification for any changes made since the previous submission.
09
Ensure that all information is accurate, complete, and properly referenced.
10
Submit the post-complete response to the FDA within the specified timeline.
11
Follow up with the FDA for any additional clarifications or questions they may have.

Who needs gdufa ii post-complete response?

01
Pharmaceutical companies and applicants who have received a complete response letter from the FDA regarding their pending generic drug user fee act (GDUFA II) application, and are required to provide a post-complete response to address the issues raised in the initial response.
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GDUFA II post-complete response refers to the final documentation submitted by a generic drug applicant to the FDA after completion of the review process.
Generic drug applicants are required to file GDUFA II post-complete responses.
The GDUFA II post-complete response should be filled out accurately and in accordance with the FDA guidelines.
The purpose of GDUFA II post-complete response is to provide the FDA with updated information on the status of the generic drug application.
The GDUFA II post-complete response must include updated information on the manufacturing process, labeling, and any changes in the application.
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