ABSTRACT
Overview ............................................................................................................. 78 Laws, Regulations, and Guidances ..................................................................... 79 Development of the NDA ................................................................................... 83 Format and Content of the NDA ......................................................................... 86
Module 1: Administrative and Prescribing Information ................................ 87 Section 1.1: Forms-Application Form [21 CFR 314.50(a)].................... 88 Section 1.1: Forms [User Fee Cover Sheet (Form FDA 3397)] ................ 92 Section 1.2: Cover Letter/Index [21 CFR 314.50(b)] ................................ 92 Section 1.3.2: Field Copy Certification [21 CFR 314.50(d)(1)(v)] ........... 92 Section 1.3.3: Debarment Certification [FD&C Act 306(k)(1)] ................ 92 Section 1.3.4: Financial Certification and Disclosure [21 CFR Part 54] .. 92 Section 1.3.5.1: Patent Information [21 CFR 314.50(h) and 314.53] ....... 93 Section 1.3.5.2: Patent Certification [21 CFR 314.50(i) and 314.52] ....... 94 Section 1.12: Other Information [21 CFR 314.50(g)] ............................... 94 Section 1.14: Labeling [21 CFR 314.50(e)] .............................................. 94
Module 2: Common Technical Document-Summary (21 CFR 314.50) ....... 94 Section 2.2: Introduction to the Summary Documents ............................. 94 Section 2.3: Quality Overall Summary ..................................................... 94 Section 2.4: Nonclinical Overview ............................................................ 95 Section 2.5: Clinical Overview .................................................................. 95 Section 2.6: Nonclinical Written and Tabulated Summaries ..................... 95 Section 2.7: Clinical Summary .................................................................. 95
Module 3: Quality .......................................................................................... 95 Module 4: Nonclinical Study Reports ............................................................ 95 Module 5: Clinical Study Reports .................................................................. 95 Mapping the Content of the NDA to the CTD Format................................... 95
Submission and Review of the NDA .................................................................. 97 Step 1: Ensure Readiness for Application through Presubmission Activities...................................................................................................... 97 Step 2: Process Submission ............................................................................ 99 Step 3: Plan Review of the Application ......................................................... 99 Step 4: Conduct Scientific/Regulatory Review of the Application .............. 100
The submission of a new drug application (NDA) to the Food and Drug Administration (FDA) is an official request by a pharmaceutical company (applicant) to sell and market a drug in the United States. When complete, an NDA will contain thousands of pages of nonclinical, clinical, and drug chemistry information that supports the proposed labeling of the product.
