New Drug Application - Kendall Life Sciences LLC
Specialized Business & Compliance Consulting Group

New Drug Application (NDA)
 

Prescription Drug Evolution

How our team can guide you through the entire journey

New Drug Application (NDA)

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The regulatory requirements that govern the contents of an NDA are intended to give FDA enough information to make a meaningful evaluation of a drug. The specific NDA data requirements are lengthy and detailed, covering several broad categories: 1) preclinical data; 2) human pharmacokinetic and bioavailability data; 3) clinical data; 4) a description of proposed methods by which the drug will be manufactured, processed and packed; 5) a description of the drug product and drug substance; 6) a list of each patent claiming the drug, drug product or method of use, or a statement that there are no relevant patents making such claims; and 7) the drug’s proposed labeling. The NDA must also contain various regulatory certifications and may require risk evaluation mitigation strategy (REMS).

The Challenge

In addition to meeting the specific data requirements and REMS, applicants face several other requirements and hurdles in their submission of the NDA application. The Prescription Drug User Fee Act (PDUFA) levies a user fee on certain human drug applications. Additionally, the FDA will only receive an NDA application for filing if it is sufficiently complete to permit a substantive review. If an NDA application fails to meet this standard, the FDA may also utilize its authority to refuse to file (RTF) the NDA application.

The Strategy

Careful planning and preparation is key in successfully submitting a drug application. KLS’ industry experts can provide the necessary experience and insight to counsel and assist in the preparation and submission of an NDA application so that the NDA is successfully filed by the FDA for review. KLS can also provide valuable counsel to companies in the development of goals and timelines for PDUFA fees and submission, including complete response letter(s) and resubmission(s) and/or requested end-of-review conference(s), if applicable.

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