Inside FDA Review: Crafting a Quality ANDA Labeling Submission
Gain regulatory insights and learn directly from a former FDA reviewer how to craft high-quality ANDA submissions and avoid common
pitfalls that lead to CRLs.
Date: July 22, 2025
Time: 10:00-11:00AM US EST / 4:00-5:00 PM CEST
About the Webinar
Getting your ANDA submission right the first time is critical to avoiding costly delays—and labeling is one of the most common reasons for FDA deficiencies or comments. Join us for a deep dive into the FDA’s expectations for ANDA labeling submissions, led by a former FDA labeling reviewer with unmatched insight into the Agency’s review process.
This session will walk you through strategies to avoid Agency communication (e.g., CRLs, DRLs, Information Requests, etc.) streamline labeling in the context of patent and exclusivity concerns, and prepare Module 1 documentation that meets FDA expectations. Whether you're preparing for first-cycle approval or revising a past submission, this webinar provides actionable guidance to help you succeed.
What You'll Learn
- Top reasons ANDAs are delayed or receive Agency communication—and how to prevent them
- Common pitfalls in labeling tied to patent certifications, method-of-use carve-outs, and overlapping exclusivity issues
- Best practices for Module 1 preparation and labeling alignment
- FDA’s evolving expectations—and how to prepare for first-cycle approval
Register today to ensure you don't miss this rare opportunity to gain insight and advice directly from a former FDA Labeling Reviewer.
Unable to join? Register and you will receive the recording after the live session.
Meet the Host
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Marshall Florence
Vice President, Labeling
View Bio
Marshall Florence
Marshall Florence, PharmD, recently joined ProPharma’s Regulatory Sciences team as Vice President, Labeling. Prior to ProPharma, Dr. Florence served as Supervisory Pharmacist in the Division of Labeling Review with the US Food and Drug Administration. Dr. Florence has over 10 years of experience performing secondary review and approval of drug product labeling, including Prescribing Information, Medication Guides, Carton/Container Labels, and all related clinical materials for approval to U.S. market, ensuring FDA regulations are consistently applied, in accordance with approved regulations and guidance, and describing the safe and effective use of drug products. He established and led the Best Pharmaceuticals for Children Act (BPCA) Working Group at FDA where he served as the pediatric information expert. He also served as Member of Pediatric Research Equity Act (PREA) Working Group to develop a new PREA FDA Guidance Document and Member of the Safety Labeling Group where he was responsible for reviewing safety issues identified in the marketplace and communicating recommendations to help improve the safety profile.
Marshall is responsible for providing strategic regulatory and compliance advisory services to pharmaceutical, biotech, and medical device companies. He partners closely with C-suite executives, compliance leaders, legal teams, and regulatory affairs functions to guide product communications, promotional review, and labeling development across all phases of the product lifecycle. Marshall leads cross-functional teams on Regulatory, Promotional Review (RPR), and Labeling Strategy (LS) projects, offering expert insight into FDA promotional regulations, OPDP submissions, and infrastructure development to support compliant product launches and ongoing communications.
Dr. Florence is a member of the American Pharmacists Association and holds a Doctor of Pharmacy from Duquesne University, Mylan School of Pharmacy in Pittsburgh, Pennsylvania.