The document summarizes the key aspects of the new drug application (NDA) and abbreviated new drug application (ANDA) processes in the United States. It describes the requirements for NDAs, including the 20 sections that make up an NDA and the information contained within them. It also discusses ANDA requirements for generic drugs, such as bioequivalence studies and patent certifications that are part of the review process. The review processes for both NDAs and ANDAs by the FDA are also briefly outlined.

24. 1.0 Regional Administrative Information 1.1 ToC of Module 1 or overall ToC, including Module 1 2.1 ToC of the CTD (Mod 2,3,4,5) 2.2 Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.7 Clinical Summary 2.6 Nonclinical Written and Tabulated Summaries Module 1 Module 3 Module 4 Module 5 2.1 2.2 2.3 2.4 2.5 2.6 2.7 1.0 Quality Nonclinical Study Reports Clinical Study Reports Module 2

31. NDA Review Process

37. NDA ANDA Applicable for new drug Applicable for generic drug Take longer time ( 12-15 years) Compare to NDA less time taken(1-2 years) More expenditure of money Comparatively less Cost of drugs are more Cost of drugs are less Nonclinical studies and clinical investigations are essential Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence

40. ANDA/AADA Review Process