www.biopharminternational.com September 2019 BioPharm International eBook 7
Regulatory Sourcebook Regulatory Guidance Update
THE EDITORS OF BIOPHARM INTERNATIONAL
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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
