FDA Pathways to Expedited Drug Approval
Your drug trial was a success and now you are ready to apply for FDA approval. If you’re in a hurry to get it on the market — and who isn’t — the FDA offers six options for shortening the usual review process. The challenge is in determining which one is right for your specific product. Requirements and procedures for each of the six approval pathways are similar but slightly different. Which one offers the benefits you seek?
FDA Pathways to Expedited Drug Approval will help you navigate the various expedited review pathways, explaining the purpose of each, how you can qualify, and the application process you must follow. It also lays out concerns about too-early approval raised in Congress and elsewhere in the wake of the FDA’s recent Aduhelm approval.
The book walks you through what to expect in expedited drug review moving forward, examines the latest approval numbers and discusses how impending reforms may bring more transparency and accountability to the review process.
- Gain understanding of the context of the Aduhelm case that sparked recent legislative reforms around expedited drug review
- Take a deep dive into the Food and Drug Omnibus Reform Act (FDORA), including changes to the Accelerated Approval pathway
- Determine if an investigational product qualifies for expedited approval
- Explore insights on the current commercial value of a Priority Review Voucher — and why that continues to decrease
- The pros and cons of each expedited drug approval pathway
- Improve your communication with the FDA throughout the review process
- Identify what recent legislative reforms mean for expedited review
Ensure you understand how to make the best use of the FDA’s expedited approval programs and avoid regulatory and compliance issues with FDA Pathways to Expedited Drug Approval.
About the Contributors
Kellie Combs is a partner in Ropes & Gray’s life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group. She provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as healthcare providers and academic institutions, on a broad range of issues under the Food, Drug and Cosmetic Act and the Public Health Service Act.
Sarah Blankstein is counsel in Ropes & Gray’s life sciences group. She provides legal and strategic advice to pharmaceutical and medical device companies on a wide array of FDA regulatory matters, with a focus on regulatory risk management, promotional compliance matters, good manufacturing practices and product development.
Who Will Benefit
- Regulatory affairs and compliance department managers
- Submissions and approvals managers
- CEO/president, VP and other pharmaceutical executives
- Research and development managers
- In-house counsel
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Kellie Combs and Sarah Blankstein
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