In September 2012, the new ANDA stability guideline established the regulatory requirements for submitting an abbreviated NDA based on ICH requirements; Due to numerous questions regarding what specific stability data should be included in each ANDA submission, the Office of Generic Drugs (OGD) recently published an addendum.
As this addendum clarifies many of these requirements, an improved understanding of what items it outlines will help your team determine the key steps you need to take. This 90-minute session will introduce the development of the ICH Q1A(R2) stability guideline and how it leads to the FDA ANDA guideline. It will discuss the key factors of the new FDA stability requirements and how it may impact the analytical development sector of the generic industry.
By attending this course, you will learn:
- The role of stability programs in the drug development process
- What factors affect the stability profile of drug products
- Key information that makes the development of generics different than those work with innovator products
- The impact of the new FDA guideline to Generic Stability Program
- An overview of ICH Q1A (R2), Q1B, Q1C, Q1D, Q1E
- How to suggest a Global Stability Protocol for registration