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Development And Review Process Of NDA, ANDA/AADA and OTC

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Prof. Dr. Basavaraj Nanjwade
Prof. Dr. Basavaraj Nanjwade

This document summarizes different types of new drug applications and reviews processes in the United States, including NDAs, ANDAs, and OTC monographs. It discusses the requirements for NDAs including chemistry, manufacturing, clinical trials, and safety data. ANDAs allow for generic drug approval by referencing an already approved drug. OTC monographs provide standards for active ingredients, doses, and labeling of non-prescription drugs. The review processes for these application types and OTC monographs are also briefly outlined.

EducaçãoSaúde e medicinaNegócios
1 de 16
Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Associate Professor Department of Pharmaceutics KLE University BELGAUM – 590 010
New Drug Development Process
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object],[object Object]
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object]
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object],[object Object]
New Drug Application (NDA) Classifications ,[object Object],[object Object],[object Object],[object Object]
New Drug Application (NDA) Classifications ,[object Object],[object Object],[object Object]
NDA Review Process
ANDA/AADA (Abbreviated New Drug Application) ,[object Object]
ANDA/AADA (Abbreviated New Drug Application) ,[object Object],[object Object],[object Object]
ANDA/AADA (Abbreviated New Drug Application) ,[object Object],[object Object]
ANDA/AADA Review Process
OTC (Over-the-Counter Drug Products) ,[object Object],[object Object],[object Object]
OTC (Over-the-Counter Drug Products) ,[object Object],[object Object],[object Object]
OTC Drug Monograph Review Process
THANK YOU E-mail: [email_address] Cell No: 09448716277

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