New Drug Application (NDA)

New Drug Application (NDA) – Overview

The New Drug Application (NDA) under the US FDA’s 505(b)(1) and 505(b)(2) pathways is the formal process through which pharmaceutical medicinal products gain approval for human use.

505(b)(1) NDA: Requires submission of complete reports of investigations on the drug’s safety and efficacy.
505(b)(2) NDA: Used for products with changes such as dosage form, strength, or route of administration of drugs previously evaluated and approved by the FDA under other NDAs.

For sponsors, the key challenges are:

Understanding FDA NDA submission regulations
Identifying the appropriate Regulatory pathway for their drug development case
Developing an optimal Regulatory strategy for a successful NDA filing

Failure to submit complete information may result in the FDA issuing a Refuse-to-File (RTF) decision, which will delay approval until the deficiencies are addressed. Awareness of FDA guidance on RTF reasons and review processes helps save time and costs while ensuring timely progression through the NDA submission process.

X Pharma Plus provides end-to-end Regulatory support for NDA submissions, including:

Pre-NDA meetings and strategic consultation
Compilation, technical review, and submission of NDA dossiers
Lifecycle management, including NDA annual reports and post-approval submissions

Services

“Regulatory submission to the FDA requesting approval to market a new drug in the U.S., including clinical trial results, safety, efficacy, and manufacturing information.”

Strategic support to identify the optimal regulatory pathway for FDA NDA submissions.
Expert guidance on leveraging expedited programs such as Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations
In-depth understanding of federal regulations and submission pathways (505(b)(1), 505(b)(2), and 505(j)), including data requirements and FDA review processes.
Conducting gap analyses of developmental/source data against NDA requirements and providing mitigation strategies for identified Regulatory gaps
Compilation, technical review, and submission of NDA packages (505(b)(1) and 505(b)(2)), including Module 1 documents and application forms, published in eCTD format via FDA ESG.
Provision of NDA templates with technical information to streamline dossier preparation and eCTD submissions.
Regulatory response strategy, preparation, and timely submission of responses to FDA queries or information requests.
Support for pre- and post-submission interactions and follow-ups with the FDA throughout the NDA approval process.
NDA post-approval lifecycle management, including supplements, CBE 30, CBE, annual reports, and other post-approval submissions.
Strategic guidance and submission support in managing Complete Response Letters (CRLs) for NDAs.

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New Drug Application (NDA)