- Introduction
GDUFA and drug listing services are integral to the regulatory operations of generic drug manufacturers in the US, encompassing submission support, fee management, compliance assurance, and strategic regulatory guidance to facilitate market authorization and compliance with FDA regulations.
GDUFA (Generic Drug User Fee Amendments) and drug listing services are critical components of regulatory compliance in the pharmaceutical industry, particularly for generic drug manufacturers operating in the United States.
ANDA Submission and Support:
- Abbreviated New Drug Applications (ANDAs): Assistance in preparing and submitting ANDAs for generic drug products to the FDA.
- Prior Approval Supplements (PAS): Support for submitting PASs to request changes to approved ANDAs before they can be implemented.
- User Fee Calculation: Calculation of user fees based on the type and size of the manufacturing facility and the type of submission (e.g., ANDA, PAS).
- Fee Payment Assistance: Assistance in preparing and submitting payments to the FDA to cover user fees required under GDUFA.
- cGMP Compliance: Support in ensuring that manufacturing facilities comply with current Good Manufacturing Practices (cGMPs) as required by the FDA.
- Facility Inspections: Preparation and support during FDA inspections of manufacturing facilities to assess compliance with regulatory standards.
- Strategic Regulatory Advice: Guidance on regulatory strategies, timelines, and pathways for generic drug development and approval.
- Regulatory Intelligence: Monitoring and providing updates on changes in GDUFA regulations, guidelines, and requirements.
- Post-Approval Changes: Assistance in managing post-approval changes and supplements to maintain compliance with FDA requirements.
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NDC Assignment and Management:
- National Drug Code (NDC): Assistance in obtaining and managing NDCs for drug products marketed in the United States.
- NDC Registration: Support in registering drug products with the FDA through the electronic Drug Registration and Listing System (eDRLS). Annual Registration Renewal:
- Annual Renewal: Assistance in renewing drug product registrations annually with the FDA between October 1 and December 31. Submission and Compliance:
- Electronic Submission: Preparation and submission of drug listing information electronically to the FDA.
- Compliance Management: Ensuring that drug listings are accurate, up-to-date, and compliant with FDA regulations.
- Regulatory Monitoring: Keeping abreast of changes in drug listing regulations and guidelines to ensure ongoing compliance.
- Notification of Changes: Assisting in notifying FDA of any changes to drug listings, such as new products, labeling updates, or discontinuations. Integration and Importance:
- Regulatory Compliance: Both GDUFA and drug listing services are essential for ensuring regulatory compliance with FDA requirements for generic drug approval and marketing in the United States.
- Market Access: Proper management of GDUFA and drug listing services facilitates timely market access for generic drug products, ensuring they meet regulatory standards and are available to patients.
- Expertise and Support: Regulatory service providers offer specialized expertise and support to navigate the complexities of GDUFA and drug listing requirements, helping pharmaceutical companies streamline processes and maintain compliance efficiently.
