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.
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