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Welcome to the March-April 2019 edition of The Protocol Link Newsletter! In this issue, we present some noteworthy industry links, our own Christine Shumard-Sauer, Ph.D. explores the new Draft Guidance, Principles of Premarket Pathways for Combination Products, and the FDA's focused efforts to approve generic drugs, then conclude with a Word From Our Staff. We hope you enjoy the latest edition of The Protocol Link Newsletter and look forward to hearing from you!

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Noteworthy Links Gottlieb to Resign as FDA Commissioner ---------------------------------------- CDER Guidance Agenda for 2019: What's Coming ---------------------------------------- Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act (Final Guidance) ---------------------------------------- Quality Considerations for Continuous Manufacturing (Draft Guidance) ---------------------------------------- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Draft Guidance)

Pathways for Premarket Applications for Combination Products Authored By: Christine Shumard-Sauer, Ph.D.

On February 5, 2019, the U.S. Food and Drug Administration (FDA) issued a draft guidance, Principles of Premarket Pathways for Combination Products. The draft guidance outlines the FDA’s thinking on principles for premarket review of combination products, including how to determine which type of premarket applications are applicable. Selection of the correct premarket pathway depends on the determination of the Agency’s lead Center for the regulation of a combination product, which is assigned based on the product’s primary mode of action (PMOA). The draft discusses the various pathways available for combination products based on their PMOA, and considerations for making the correct pathway determination.

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Service Spotlight: Regulatory Affairs Your organization is called upon each day to present critical insight and guidance specific to your products' regulatory requirements for submission, approval, and continued marketing. At Protocol Link, we work with your core team as your regulatory partner and ensure deadlines are always achieved. Our regulatory, compliance, scientific, legal, and technical consultants have a wide range of expertise in regulatory responsibilities including regulatory strategy, submission preparation, eCTD publishing, lifecycle management, FDA liaison services, annual reports, product recalls, DDMAC requirements and more.

A Banner Year for Generic Drugs Authored By: Christine Shumard-Sauer, Ph.D.

The FDA has focused its efforts to approve generic drugs in the last year since they account for the vast majority of prescriptions dispensed in the United States. In 2018 alone, more than 1,000 generic drugs were approved or tentatively approved with record-breaking highs in October and November. “First generics,” approvals for generic equivalents of branded drugs that previously had no FDA-approved generic, made up nearly 10 percent of 2018 approvals and about 14 percent were for “complex generic drugs,” such as those administered transdermally or topically.

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A Word From Our Staff "We are just around the corner from completing our first quarter of 2019, which included a number of fresh project opportunities from both new and existing clients. It's exciting to be contacted by companies that have been referred to us by former as well as current clients. The recommendation serves as confirmation that we have met and continue to exceed our Clients’ expectations. We always appreciate positive feedback and I personally wanted to say thank you!" Scott Buckely, PMP Director, Protocol Link

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