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Preparing for FDA’s New Five-Year Plan Management Report

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FALLS CHURCH, Va. (PRWEB)

Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year Plan

https://www.fdanews.com/products/category/101-books/product/62121

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. Drugmakers producing these treatments and therapies need to know exactly what the rules will be and how they fit into this adjusted environment.

This FDAnews management report, 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 report also covers how drugmakers should best communicate with the FDA and answers pressing questions about 180-day exclusivities.

This management report will cover:

Reports and Data

  • a. Considering GDUFA reauthorization performance goals and program enhancements for the 2023-2027 fiscal years

  • b. Reporting on generic drugs in 2020 and monthly performance of the FDA’s Office of Generic Drugs

  • c. Listing of off-patent and off-exclusivity drugs without an approved generic

ANDA Submission Guidances and Policies

  • a. Understanding best practices, content, and format for abbreviated new drug application (ANDA) submissions

  • b. Self-identifying generic drug facilities, sites and organizations

  • c. Determining whether to submit an ANDA or a 505(b)(2) application

  • d. Referencing approved drug products in an ANDA submission

  • e. Including a variation of drug products in a single ANDA submission

  • f. Managing ANDA submissions, including prior approval supplements, refuse-to-receive standards, amendments and requests for final approvals

  • g. Handling ANDAs during COVID-19

  • h. Submitting summary bioequivalence data for ANDAs

  • i. Updating ANDA labeling and acceptability of draft labeling

  • j. Requesting reconsideration at the division level under GDUFA

ANDA Review Policies

  • a. Reviewing and approving generic drug applications

  • b. Communicating and filing ANDAs

  • c. Receiving and processing requests for voluntary withdrawals

  • d. Reviewing prioritizations, conversions and issuances of information requests or discipline review letters

  • e. Considering the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act

Communication Guidances

  • a. Using controlled correspondence related to generic drug development

  • b. Answering quality-related controlled correspondence questions

  • c. Evaluating requests for and conducting product development and presubmission meetings

  • d. Conducting formal meetings and post-complete-response-letter meetings between FDA and ANDA applicants

Exclusivity Guidances

  • a. Answering questions about 180-day exclusivity

  • b. Handling 180-day exclusivity when multiple ANDAs are submitted at once

User Fee Rates and Guidances

  • a. Showcasing drug user fee rates for the 2022 fiscal year

  • b. Assessing user fees under the Generic Drug User Fee Amendments of 2017

  • c. 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 complete guide contains all the documentation need to navigate the transition.

Management Report Details

Generic Drug Submissions Under GDUFA III:

Preparing for FDA’s New Five-Year Plan

https://www.fdanews.com/products/category/101-books/product/62121

Price:

$297

Easy Ways to Order:

Online:

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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