New Drug Application

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The New Drug Application (NDA) has a long-established history when it comes to drug approval and administration in the United States. Since 1938, every new drug that has come to the commercialized market has been subjected to and approved through the New Drug Application.

The function of a New Drug Application is for sponsors and pharmaceutical companies to provide all relevant data surrounding their new indication(s) to the Food and Drug Administration (FDA) for a comprehensive review. Upon approval, the corresponding sponsor or relating party will gain the legal right to sell and market their drug therapy.

What Products Fall Under a New Drug Application

All non-device drugs are subjected to the NDA process — therefore, the vast majority of drugs in development will need to pass through the NDA. However, multiple alternative drug application processes exist for drugs/therapies that meet specific criteria. Other drug application categories include:

What is Included in an FDA New Drug Application

The submission of an NDA requires extensive work and exhaustive attention to detail, as the application is responsible for displaying the entire history of the drug in question. Therefore, with the need to showcase the entire lifespan of the indication, the submitting party must include materials relating to:

  • Premarket requirements include:
    • Filing and maintenance of an IND
    • Pediatric Research Equity Act (PREA) requirements
      • Pediatric investigational plan, waiver, or deferral
    • Prescription Drug User Fee Act (PDUFA) fee
    • Requirements for advertisements and labeling
  • The full NDA submission must contain evidence supporting the following:
    • The drug product is safe and effective for use in patients with the specified disease
    • The drug product’s risks of use are outweighed by the benefits it provides
    • The proposed labeling and package inserts for commercialization provide all necessary information for the end-user
    • The drug is manufactured in a way that preserves its quality and properties through continuous batches

An NDA will include all information explored, tested, and gathered from the IND process. Based upon the application and supplemental documents provided, the review board of the FDA should be able to confidently make decisions on:

  • The drug’s safety and effectiveness in its proposed use(s), and whether the benefits outweigh the potential risks
  • Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity

How to Submit a New Drug Application

Submission of an NDA is organized through the common technical document (CTD) format, which is the technical standard for all agency submissions starting from the IND phase. The eCTD is regarded as the fastest delivery method to move the NDA process along between the submitting party and the FDA.

The FDA provides a list of supporting documents and links to help petitioners navigate through the NDA affair.

The Expected New Drug Application Timeline

Less than 30% of initial drug candidates proceed through the entire multi-year drug development timeline — which ends with the final step, the NDA. Therefore, if a sponsor or related pharmaceutical company reaches the NDA stage, it is critical that they finish the process successfully.

Expected timelines and related dates include:

  • The sponsor must notify FDA within 1 year of the NDA submission and can request a pre-NDA meeting with their review division to address any questions and get direct feedback
  • From submission, FDA has 60 days to first validate the dossier, and provide a filing letter to communicate their decision to continue with the review
  • Once validated, FDA has 10 months to perform their standard review of the application’s contents.
    • If a sponsor qualifies for priority review, this time is cut down to 6 months
  • Following their review, FDA will either send an approval letter or a complete response letter back to the sponsor
    • A complete response letter provides a summary of the deficiencies which will need to be addressed via amendments to the NDA
    • The approval letter authorizes the sponsor the manufacture and sells their product

New Drug Application Assistance

Due to the specifics and required detail of NDAs working with regulatory experts increases your likelihood of application approval. BioPharma Global offers a variety of benefits for those parties needing to submit and navigate the final leg of the drug development process.

With expertise in all stages and aspects of the NDA, our team of industry professionals is able to help on:

  • Regulatory strategy
  • Gap analysis
  • Document authoring
  • eCTD publishing and electronic submission
  • Pre-NDA/BLA meeting assistance
  • FDA communication

If your organization is needing to navigate the NDA submission process or has struggled to do so in the past, get in contact with us today. BioPharma Global has a proven track record of helping businesses achieve regulatory compliance and meet strict guideline standards.

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