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In this section: Regulatory Science in Action

Impact Stories

To illustrate the unique value of CDER’s regulatory science investments we have developed a series of “impact stories” that describe recent advances by our researchers and the impacts of these discoveries on drug development and the public health.

Bioequivalence testing for highly variable drugs

An adaptive trial design for testing the bioequivalence of generics of highly variable drugs

December 15, 2023

Pharmaceutical Drugs

Biorelevant Pediatric Dissolution Methodology

December 11, 2023

Woman working at desk monitoring multiple screens

Gadolinium-based contrast agents for MRI: safety in pregnancy

August 15, 2023

lamotrigine

FDA shows generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study

July 26, 2023

BBB QSAR Model

New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability

April 19, 2023

Impact Story AI Thumbnail

Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics

February 8, 2023

hands holding cell phone

Prescription drug promotion in online character space limited (CSL) communication

December 27, 2022

Scientists using tablet in lab

Assessing the Impact of Opioid Overdose and Opioid Antagonist Dosing to Support Medical Product Development

December 22, 2022

Impact Story ASD

Formulating Drug Products for Optimized Absorption: Elucidating Amorphous Solid Dispersions

August 30, 2022

Women pointing at figure on monitor screen

Designing Sound Clinical Trials That Incorporate Real-World Data

August 19, 2022

OTS Adult to Pediatric

Applying the Non-inferiority Paradigm to Assess Exposure-Response and Dosing Comparisons Between Pediatric and Adult Patients

August 16, 2022

Impact Story In Vitro Test Factors

Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

May 23, 2022

Raman scattering

Through-Container Quantitative Screening of Hand Sanitizers

March 18, 2022

Diclofenac

How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product

December 1, 2021

Injectable suspension impact story thumbnail from OTS

New In Vitro Methods to Understand and Mitigate Clinical Variability Associated with Injectable Suspensions

December 2, 2021

Impact Story - Pediatric dosing

Improving Dose Selection In Children through Better Estimates of Renal Function

November 19, 2021

Impact Story - Antibiotics

Exploiting Real-World Data to Optimize the Use of Antibiotics

November 9, 2021

Microphysiology

Three-Dimensional (3D) Cell Culture (Microphysiological) Platforms as Drug Development Tools

August 23, 2021

Manufacturuing

Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins

August 20, 2021

Drug Advertising

Advancing Our Understanding of How Drug Promotion Influences Consumers and Health Care Providers

August 19, 2021

Pregnant Woman holding a pill and a glass of water

Physiologically Based Pharmacokinetic Modeling of Sertraline Dosing in Pregnancy

August 16, 2021

A man holding nasal spray canister in one hand, and inserting canister tip into nose.

How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products

April 28, 2021

cyber brain

A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response

April 26, 2021

Person sitting at desk typing on laptop with clipboard and stethoscope nearby

Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

December 11, 2020

Impact Story - Metastatic Breast Cancer

Use of Cyclin-Dependent Kinase 4/6 Inhibitor with Hormonal Therapy in Metastatic Breast Cancer—Efficacy in Patient Subgroups

November 16, 2020

Impact Story - Schizophrenia

Improving the Design of Clinical Trials of Drugs to Treat Schizophrenia

November 10, 2020

ANDAs Impact Story

A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications

October 28, 2020

Figure 2. Comparison of DOM and ROM statistical analyses.

CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products

June 23, 2020

Rows of white dots connected by blue lines to indicate a neural network

Modeling Tools Could Modernize Generic Drug Development

June 2, 2020

Impact Story: CDER Assessment of Drug Impurity Mutagenicity by Quantitative Structure-Activity Relationship Modeling

CDER Assessment of Drug Impurity Mutagenicity by Quantitative Structure-Activity Relationship Modeling

May 15, 2020

White pills on paper with EKG trace

Improved Assessment of Cardiotoxic Risk in Drug Candidates: The Comprehensive in vitro Proarrhythmia Assay

March 6, 2020

Female doctor speaking with a female patient

Using innovative statistical approaches to provide the most reliable treatment outcomes information to patients and clinicians

June 10, 2019

A daughter hugging her sick mother wearing a scarf

Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

February 21, 2019

A female scientist wearing PPE and using a white tablet

Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling

February 21, 2019

A scientist wearing purple gloves using a mass spectrometer

Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics

December 4, 2018

A scientist wearing gloves pipetting liquid on to chip held with forceps

Evaluating the Potential of Microengineered Human Cellular Systems to Predict Drug Effects in the Clinic

October 5, 2018

Female doctor listening to the lungs of a patient

A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

August 13, 2018

Rows of white dots connected by blue lines to indicate a neural network

Capturing Patient Experience Through Deep Learning

August 13, 2018

A pile of mixed pills on a wood table

Preclinical Research to Achieve Safer Prescribing of Psychoactive Therapeutics for Patients Who Use Opioids

August 9, 2018

Two female scientists wearing goggles consulting on lab results

Developing the Tools to Evaluate Complex Drug Products: Peptides

October 2, 2017

White pills on paper with EKG trace

Finding a Better Test for Predicting the Risk Drugs Pose to the Heart

June 22, 2017

Rack filled with test tubes containing orange liquid

Regulatory Science is Strengthening U.S. Drug Product Manufacturing

June 22, 2017

Woman applying face cream on her cheek bone while looking in a mirror

Developing New Ways to Evaluate Bioequivalence for Topical Drugs

September 22, 2017

Drug manufacturer wearing PPE and holding a white pill with their thumbs and index fingers

Addressing Concerns About the Quality of Generic Drugs for Treating Epilepsy

September 22, 2017

Elderly couple using a computer while sitting on a sofa

Helping to Better Communicate the Risks and Benefits in Prescription Drug Advertising

September 22, 2017

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