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NDA: New Drug Application & Its Contents

Raina Rahul Agarwal 26 May, 2022 Clinical Research No Comments
New Drug Application

What Is New Drug Application

New Drug Application is to obtain approval for marketing and sale of the new drug after the phase-3 clinical trial. It is a  request by the sponsor to the FDA. It is a document that provides animal and human studies data, pharmacology studies, toxicology studies, and dosage and also contains the drug manufacturing process.

The goal of the New Drug Application is to provide adequate information to the FDA to ensure the safety and efficacy of the drug. If NDA is submitted then it takes 60 days for approval. FDA access the following key points:

  • Whether the drug is safe and effective in its proposed use and whether the benefits of the drug overweight the risk.
  • Whether the drug’s proposed labelling is appropriate and what it should contain.
  • Whether the drug manufacturing methods and controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality and purity.

After reviewing New Drug Application, FDA approves one of the three mentioned letters:

  1. Approval Letter: The approval letter indicates the drug has been approved.
  2. Approvable Letter: It indicates that the drug will be approved eventually, but there are some points which have to be rectified.
  3. Non-Approvable Letter: Non Approval letter indicates the drug can not be approved with the list of supporting documents.

What Is Form-44

Form44 is an application which is used to grant permission for the marketing and sale of new drugs. The sponsor submits this form for approval under the provision of the Drug & Cosmetic Act 1940 and Rules 1945.

Form 44 collected data during the clinical studies and human clinical studies of an investigational new product made a part of the NDA.

Form 44 provides adequate and enough information to permit the approval of a new drug.

Classification Of NDA According TO CDER:

  • New molecular entity
  • New salt of a previously approved drug
  • A new formulation of a previously approved drug
  • A new combination of two or more drug
  • Already marketed drug product
  • New indication of an already marketed drug
  • Already marketed drug ( No previously approved NDA
  • Duplication

Contents Of New Drug Application: (As per schedule Y with indexing and page no.)

  • Introduction ( Brief description of the drug and the therapeutic class to which it belongs)
  • Chemical and Pharmaceutical information
  • Animal Pharmacology
  • Animal Toxicology
  • Human/Clinical Pharmacology phase-1
  • Therapeutic exploratory trials (Phase-2)
  • Special Studies (Geriatrics, paediatrics, pregnant or nursing women)
  • Regulatory status in other countries
  • Prescribing information
  • Samples and Testing Protocol/s

Disclaimer: All the content of this article is for information purposes only.


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Raina Rahul Agarwal
My name is Raina Agarwal, and I am a seasoned content writer with three years of experience in the field. Holding a master's degree in microbiology. I have also garnered valuable experience as a microbiologist, with a career spanning over a decade since 2011. My diverse professional background enables me to offer unique insights and perspectives in my content creation endeavours.

Raina Rahul Agarwal

A Non-Medical Scientist, BSL-2 Lab, Mirzapur

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