NDA 204442 Approval for PROBUPHINE Implant
This file contains the NDA approval details for PROBUPHINE (buprenorphine hydrochloride) implant. It outlines important labeling, submission instructions, and pediatric study requirements. Essential for pharmaceutical companies working with opioid dependence treatments.
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How do I fill this out?
To fill out this NDA application, ensure that all required fields are filled accurately. Follow the specific instructions for structured product labeling as outlined in the FDA guidelines. Review all submitted information for compliance with federal regulations.
How to fill out the NDA 204442 Approval for PROBUPHINE Implant?
1
Gather all necessary documents and data for the NDA application.
2
Complete the structured product labeling in compliance with FDA standards.
3
Ensure all required signatures and endorsements are obtained.
4
Submit the completed application through the FDA's eLIST system.
5
Monitor the submission for any further requests from the FDA.
Who needs the NDA 204442 Approval for PROBUPHINE Implant?
1
Pharmaceutical companies managing opioid dependence treatments.
2
Regulatory affairs professionals ensuring compliance.
3
Healthcare providers prescribing buprenorphine products.
4
Researchers conducting studies on opioid addiction.
5
Patients seeking information on treatment options.
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What are the instructions for submitting this form?
To submit this NDA application, please send all required documents electronically via the eLIST system. Ensure to include your contact information and all parts of the application, as specified in the FDA guidelines. For any concerns, please reach out to the approval team at the FDA using the provided contact information.
What are the important dates for this form in 2024 and 2025?
Important dates include the final protocol submissions by March 2017 and annual interim reports from March 2018 to March 2020. Adhere to these timelines for reporting and compliance purposes. Stay updated with any amendments or submissions required by the FDA.
What is the purpose of this form?
The primary purpose of this NDA form is to secure regulatory approval for the PROBUPHINE implant, designed to treat opioid dependence. This process is essential for ensuring that pharmaceutical products meet the required safety and efficacy standards before entering the market. It acts as a formal request for approval, detailing the product's intended use, safety data, and proposed labeling information.
Tell me about this form and its components and fields line-by-line.
- 1. Applicant Information: Details regarding the pharmaceutical company and key contacts.
- 2. Product Information: Information about the NDA product, including its formulation and intended use.
- 3. Clinical Study Data: Data supporting the safety and efficacy of the product through clinical trials.
- 4. Labeling Information: The proposed labeling and package insert details that comply with regulatory standards.
- 5. Pediatric Study Commitment: Evidence of compliance with pediatric study requirements, if applicable.
What happens if I fail to submit this form?
Failure to submit this form can result in delays in the approval process for the new drug application.
- Approval Delays: Inadequate submissions can extend the timeline for getting the drug to market.
- Non-Compliance Issues: Submitting incomplete forms may lead to regulatory scrutiny and potential penalties.
- Impact on Patients: Delays could affect access to necessary treatment options for opioid dependence.
How do I know when to use this form?
- 1. New Drug Applications: Required for all new formulations seeking FDA approval.
- 2. Labeling Changes: Necessary when modifications to existing drug labeling are made.
- 3. Pediatric Study Compliance: Used to submit data relevant to pediatric studies as required by law.
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