Related Experiment Video
Updated: Dec 3, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact
Kevin Bugin1, Janet Woodcock2, Peter Stein2
1Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. kevin.bugin@fda.hhs.gov.
The Food and Drug Administration modernized its New Drugs Regulatory Program to streamline drug review and enhance safety. This initiative improves efficiency and adapts to scientific advancements in drug development.
Area of Science:
- Regulatory Science
- Pharmaceutical Policy
Background:
- Increased drug development activity necessitated modernization of regulatory processes.
- The Food and Drug Administration's Center for Drug Evaluation and Research initiated a multi-year effort in 2017.
Purpose of the Study:
- To modernize the New Drugs Regulatory Program.
- To adapt to innovations in science, technology, and drug development.
- To improve efficiency and effectiveness of drug regulation.
Main Methods:
- Restructured the Office of New Drugs with therapeutic alignment and new cross-functional offices.
- Implemented an interdisciplinary review process for new drug and biologics applications.
- Streamlined the investigational new drug (IND) review process.
Main Results:
- Enhanced regulatory support through new offices.
- Reduced redundancy and improved clarity in review documents.
- Initiated a streamlined IND review process.
Conclusions:
- The modernization effort positions the New Drugs Regulatory Program for continuous improvement.
- The program will better adapt to scientific and technological innovations.
- Future efforts will focus on staff retention, safety monitoring, and data standardization.
More Related Videos
10:17High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
07:02A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
Related Concept Videos
Drug Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
FDA Approved Drugs: Changes to Approved Drugs
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Products: Biologics, Biosimilars and Interchangeables