New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact.

Content Provider	Europe PMC
Author	Bugin, Kevin Woodcock, Janet Stein, Peter Sharma, Khushboo Tyberg, Yonatan
Abstract	In response to a rapid increase in drug development activity during the past two decades, the Food and Drug Administration’s Center for Drug Evaluation and Research launched a multi-year effort in 2017 to modernize the program by which new drug products are regulated, known as the New Drugs Regulatory Program. Following a detailed analysis of FDA activities in new drug development, premarket review, and postmarket monitoring, the Office of New Drugs was restructured to therapeutically align its clinical offices and to add new cross-functional offices for regulatory support. An interdisciplinary review process for new drug and biologics applications was rolled out to reduce redundancy and produce review documents that effectively communicate the scientific basis for the regulatory decision. The investigational new drug (IND) review process was also streamlined. During the next 2 years, the modernization initiative will seek to attract and retain new scientific and regulatory staff, improve postmarket safety monitoring, increase efficiency of drug review via technology-enabled workflows, and standardize the capture and use of scientific data to inform future regulatory decisions. The modernization effort will position the New Drugs Regulatory Program to continually improve and adapt to innovations in science, technology, and drug development.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC7587163&blobtype=pdf
ISSN	21684790
Journal	Therapeutic Innovation & Regulatory Science [Ther Innov Regul Sci]
Volume Number	55
DOI	10.1007/s43441-020-00234-z
PubMed Central reference number	PMC7587163
Issue Number	2
PubMed reference number	33105018
e-ISSN	21684804
Language	English
Publisher	Springer International Publishing
Publisher Date	2020-10-26
Publisher Place	Gewerbestrasse 11, Cham, Ch 6330, Switzerland
Access Restriction	Open
Rights License	This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. © The Drug Information Association, Inc 2020
Subject Keyword	Reorganization Program improvements Modernizing FDA Drug development
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health Pharmacology, Toxicology and Pharmaceutics Pharmacology (medical)