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

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

Topic Background:

A generic drug product is equivalent to a patented drug product in terms of dosage, strength, route of administration, quality, performance characteristics and intended use. Generic drug applications are indicated as abbreviated because they are generally not required to include preclinical and clinical trials to establish safety and effectiveness. In place of clinical trials, generic applicants must demonstrate that their product is bioequivalent to the originally patented drug.

As part of this process, firms submitting ANDAs are required to submit user fees that are intended to improve the CDERs ability to perform their critical functions in this regard. The user fees were initially enacted under the Generic Drug User Fee Amendment in 2012 to help the FDA ensure that participants of the U.S. generic drug system comply with U.S. quality standards, and to increase the likelihood that American consumers will get timely access to low cost, high quality generic drugs.

In 2017, the FDA signed into law, the first reauthorization of the Generic Drug User Fee Amendments (GDUFA II). This reauthorization substantially alters the fee structure of this program. Recently the FDA finalized guidance to help review the goals established as part of this reauthorization as they apply to ANDAs and PASs (Prior Approval Supplements).

Together, the ANDA process and the Generic Drug User Fee Amendments Reauthorization of 2017 form the structure of our US generic medications process.

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