Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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6 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Guidance Update R egulatory agencies and pharmacopeia organizations revised policies and guidelines in 2019. FDA issued guidance docu- ments that address patient-centric drug development, bio- similars, and a variety of biologics application guidelines. The US Pharmacopeial Convention (USP) also proposed some changes to monographs. The following are a few notable actions 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 Admin- istration Reauthorization Act of 2017 Title I (1). There will be four guidance documents on methodological patient-focused drug de- velopment in the series, and they will address how stakeholders can collect and submit patient data and other relevant patient informa- tion 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 ad- dress refining the list of important impacts and concepts to develop study instruments, and the fourth guidance will address methodolo- gies, standards, and technologies for the collection, capture, storage, and analysis of clinical outcome assessment data. What's New in Regulations and Compliance The Editors of Pharmaceutical Technology Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. POLARPX - STOCK.ADOBE.COM

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