BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page 6 of 44 September 2019 BioPharm International eBook 7 Regulatory Sourcebook Regulatory Guidance Update THE EDITORS OF BIOPHARM INTERNATIONAL Polarpx - STOCK.ADOBE.COM This article reviews a few of the notable actions FDA has taken in 2019. F DA issued guidance documents in late 2019 that address patient-centric drug development, biosimilars, and a variety of biologics applica- tion guidelines. The following are a few notable actions the agency has taken this year. DRUG DEVELOPMENT FDA is developing a series of guidance documents as part of the agency's patient-focused drug development efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I (1). There will be four guidance documents on methodological patient-focused drug development in the series, and they will address how stakeholders can collect and submit patient data and other relevant patient information for the development of medical products. The first guidance, Collecting Comprehensive and Representative Input, will discuss sampling methods used when planning to collect patient input. Guidance number two, Methods to Identify What is Important to Patients, will discuss methods for eliciting information from patients identified in guidance one and gathering information on symptoms and impact on patients. The third guidance will address refining the list of important impacts and concepts to develop study instruments, and the fourth guidance will address methodologies, stan- dards, and technologies for the collection, capture, stor- age, and analysis of clinical outcome assessment data. What's Happening in Regulatory Guidance for Biologics

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