The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing Over-the-Counter Monograph Submissions in Electronic Format," on July 25, 2024. This guidance outlines the procedures for submitting over-the-counter (OTC) drug monograph submissions electronically, ensuring a streamlined and efficient process.
The FDA's guidance aims to facilitate the electronic submission of OTC monograph submissions, including new submissions, amendments, and other communications related to OTC drug products. The move towards electronic submissions is part of the FDA’s broader initiative to modernize and streamline the regulatory process.
The guidance provides context on the regulatory framework governing OTC drugs in the United States. OTC monographs are essentially "rule books" for each therapeutic category, covering acceptable ingredients, doses, formulations, and labeling. They allow products to be marketed without FDA pre-approval, provided they comply with the monograph's requirements.
The CDER NextGen Portal is the primary platform for submitting electronic OTC monograph submissions. The FDA provides specific instructions for securely submitting confidential information, including proprietary data and sensitive business information, ensuring its protection and proper handling. The guidance details several key considerations:
Presubmission Considerations for the CDER NextGen Portal
Manufacturers should ensure they are registered and have the necessary credentials to access the portal.
It is advised to prepare all submission documents by FDA’s specifications before initiating the submission process.
Transmitting Electronic Submissions in the CDER NextGen Portal
The guidance outlines the steps for uploading and transmitting documents securely via the portal, including file format requirements and technical specifications.
Receipt Date for CDER NextGen Portal Submissions
The FDA acknowledges the receipt date of submissions as the date the complete document is uploaded and received by the portal. This date is crucial for regulatory timelines.
Contact Information
The guidance provides contact details for technical support and inquiries related to the CDER NextGen Portal.
OTC Monographs@FDA Portal serves as an alternative or supplementary platform for electronic submissions. It offers similar functionalities and is integrated with the CDER NextGen Portal for seamless processing of OTC monograph submissions.
The Electronic Drug Registration and Listing System underscores the importance of maintaining up-to-date registration and listing information for OTC drug products. This system complements the submission process by ensuring all relevant product information is readily accessible to the FDA.
For more detailed information, refer to the full guidance document.
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