Based on the information provided below and discussed in class, prepare a 3 – 4 page report
outlining recommendations for preparation, submission, and maintenance of a New Drug Application
The NDA is the vehicle Sponsors use to propose the FDA approve a drug for sale in the United
States, and the goals of the NDA are to allow FDA personnel reviewing the application to determine
whether the drug has an acceptable risk-benefit profile for the proposed indication and whether the
labeling is appropriate for proper use of the drug. It must allow the FDA to determine whether
manufacturing and controls allow the product to be made reliably and of consistently high quality.
NDA submission is a pivotal moment in the transformation of a scientific concept into a
therapeutic commodity, and its review marks FDA’s last chance to determine whether a drug is safe and
effective before it can be administered to the general public. Following FDA approval, routine yet very
important activities, such as postmarket surveillance and safety reporting, are required to maintain an
approved NDA, and therefore, an approved drug on the market available to patients.
Getafix Pharmaceuticals is a small pharmaceutical company developing a compound it hopes to
market someday for treating Alzheimer’s disease. The company has maintained an effective IND for over
10 years, to which over 100 IND amendments containing a variety of documents have been submitted
(e.g. nonclinical reports, meeting materials, safety reports, manufacturing changes, clinical study
protocols and reports). Now, with promising phase II results and two global, parallel phase III clinical
studies underway, Getafix hopes to submit an NDA to FDA within two years. With limited resources and
expertise, the company has requested your help as a Regulatory Affairs Consultant.
Outline operational and strategic considerations Getafix should take into account throughout
NDA preparation. Within your plan, provide a brief introduction describing the purpose of the NDA and
its review by the FDA. Indicate whether you would recommend a Pre-NDA meeting with FDA, and if so,
describe the contents of required meeting material and potential goals of the meeting. Describe
documentation required for initial NDA submission and outline post-approval activities Getafix would
need to perform to keep the drug on the market in the United States. Also, consider the possibility of an
Advisory Committee Meeting and outline steps needed to prepare for this during NDA preparation.
Justify your recommendations by referencing applicable regulations from 21 CFR and advice from FDA
Guidances and ICH Guidelines.