Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year Plan
With the FDA’s recent commitment letter and Congress set to reauthorize the Generic Drug User Fee Act, there will most certainly be changes coming to the regulatory landscape around generic drugs. Companies producing these treatments and therapies need to know exactly what the rules will be and how they fit into this adjusted environment.
Are you developing a generic drug that will soon need approval? Is your brand-name drug approaching the end of its exclusivity period, opening the field to generic versions?
This FDAnews book, Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year Plan, is a comprehensive guide to navigating the regulations around generic drug applications, complete with agency documentation and guidance. It contains details on submission practices, applications during COVID-19, marketing and labeling, communication recommendations, exclusivity answers and fees.
This future-focused compilation includes 43 documents, all essential to better understanding the state of generic drug regulations. These resources include the FDA’s 2023-2027 commitment letter, data on the past performance of the agency’s generic drugs program, and a complete look at ANDA submission guidelines and policies. The book also covers how organizations should best communicate with the FDA and answers pressing questions about 180-day exclusivities.
This book will cover:
- Reports and Data
- Considering GDUFA reauthorization performance goals and program enhancements for the 2023-2027 fiscal years
- Reporting on generic drugs in 2020 and monthly performance of the FDA’s Office of Generic Drugs
- Listing of off-patent and off-exclusivity drugs without an approved generic
- Understanding best practices, content, and format for abbreviated new drug application (ANDA) submissions
- Self-identifying generic drug facilities, sites and organizations
- Determining whether to submit an ANDA or a 505(b)(2) application
- Referencing approved drug products in an ANDA submission
- Including a variation of drug products in a single ANDA submission
- Managing ANDA submissions, including prior approval supplements, refuse-to-receive standards, amendments and requests for final approvals
- Handling ANDAs during COVID-19
- Submitting summary bioequivalence data for ANDAs
- Updating ANDA labeling and acceptability of draft labeling
- Requesting reconsideration at the division level under GDUFA
- Reviewing and approving generic drug applications
- Communicating and filing ANDAs
- Receiving and processing requests for voluntary withdrawals
- Reviewing prioritizations, conversions and issuances of information requests or discipline review letters
- Considering the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act
- Using controlled correspondence related to generic drug development
- Answering quality-related controlled correspondence questions
- Evaluating requests for and conducting product development and presubmission meetings
- Conducting formal meetings and post-complete-response-letter meetings between FDA and ANDA applicants
- Answering questions about 180-day exclusivity
- Handling 180-day exclusivity when multiple ANDAs are submitted at once
- Showcasing drug user fee rates for the 2022 fiscal year
- Assessing user fees under the Generic Drug User Fee Amendments of 2017
- Considering the Generic Drug User Fee Amendments of 2012 and the self-identification of facilities, review of submissions, inspections and compliance
Understanding exactly how ANDAs are reviewed and what the approval process is like at the FDA is essential to a successful submission. This compilation book is the guide you need to ensure you are on track with your applications and finding the most effective path forward for your drug.
Our complete guide contains all the documentation you and your team need to navigate the transition.
Who Will Benefit
- Manufacturers of generic drug products
- Manufacturers of brand-name drugs approaching the end of their exclusivity period
- Law firms and patent consultants advising generic drug companies
- Regulatory staff
- Submissions and approvals staff
- Commercial operations team members
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