ANDA Submission and GDUFA Guidance

Why Should You Attend:

Anyone participating with the submittal process must understand how the process is structured and operated in order to bring generic pharmaceuticals and therapeutic products to market properly, successfully, and expeditiously. Furthermore, with the passing of GUFDA II, which drastically alters the fee structure, it is critical to comprehend the program's fundamental changes as well as their implications for the generics market.

Areas Covered in the Webinar:

• Overview of the ANDA and PAS processes
• Overview of GDUFA
• The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs.
• How ANDA or PAS deficiencies that will cause the FDA to request a major amendment or classify deficiency responses as a major amendment.
• The amendment format and submission process.
• The FDA's review goals for amendments under GDUFA II.
• How the FDA will process amendments submitted before GDUFA II.
• How to request that the FDA reconsider classifying a major amendment.
• A discussion of how high quality standards are maintained through inspections and risk-based approaches.
• The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated active pharmaceutical ingredients.
• The intent of the FDA to expedite product access.
• How amendment submissions may affect review goal dates.

Who Will Benefit:

The audience for this webinar would consist of anyone in the generic pharma business in the following functions:

• Compliance and regulatory,
• Research & development,
• Quality assurance.
• Positions would include – Director,
• Associate Director,
• Manager
• Associates