NDA/ANDA Submissions

A New Drug Application (NDA) is a document wherein drug sponsors formally propose that the FDA approve a new pharmaceutical drug for sale and marketing in the United States. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA. The NDA allows the FDA reviewer to determine:

  • Whether the drug is safe and effective in its proposed use(s)
  • Whether the benefits of the drug outweigh the 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[1]

An Abbreviated New Drug Application (ANDA) contains information that provides for FDA review and approval of a generic drug product. After FDA approval, an applicant may manufacture and market the product to the American public. “Abbreviated” is used because ANDA does not require applicant to include pre-clinical and clinical data to establish effectiveness and safety of the drug. However, applicants must demonstrate that their product is bio-equivalent to that of the innovator drug.

We can assist you in preparing the data to support your application and we can help you prepare, assemble, and review the required documents and reports. At PSC we know how important it is to you to speed up an FDA review and get your product to market faster. We strive to maintain a relationship of mutual trust and respect with regulatory agency personnel, and to develop a pattern of proactive communication with agencies to promote timely decision-making and progress toward completion. With our continued positive interactions with regulatory agencies we can help you achieve your goals faster.

[1] “New Drug Application.” New Drug Application (NDA). Food and Drug Administration, n.d. Web. 21 Feb. 2013.

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