ANDA Submission and GDUFA Final FDA Guidance

An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.

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.

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions. In addition, with the passage of GUFDA II which significantly changes the fee structure, it is also crucial to understand the major changes to the program, and the effects of those changes on the generics industry.

Areas Covered in the Session :

• Overview of the ANDA and PAS processes
• Purpose and scope of GDUFA II
• The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs
• The amendment format and submission process
• The FDA review goals for amendments under GDUFA II
• How the FDA will process amendments submitted before GDUFA II
• How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment
• How to request the FDA to reconsider classifying a major amendment
• 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 (APIs)
• The intent of the FDA to expedite product access
• How amendment submissions may affect review goal dates

Who Should Attend:

• Compliance and regulatory affairs professionals
• Project managers
• QA & QC managers
• R&D staff
• Generic drug manufacturers
• API manufacturers
• ANDA sponsors
• Consultants
• Directors, associate directors and associates
• Generic drug industry professionals