Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                News & Events for Human Drugs

News & Events for Human Drugs

                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective Home
          Drugs
          News & Events for Human Drugs
          More Spotlight on CDER Science ArticlesNews & Events for Human Drugs More Spotlight on CDER Science Articles
  
  	
    Share
    Post
    Linkedin

    Email
    PrintSpotlight on CDER Science
2023

Safety Outcomes When “Switching” Between Biosimilars and Reference Products
	Computational Simulations Shed Light on Factors Affecting Nasal Spray Distribution
	Bispecific Antibodies: An Area of Research and Clinical Applications
	Laboratory Study Shows Oral Antacid Drug Performs Differently When Mixed with Various Food Vehicles
	Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
	The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints
	Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development2022

Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs
	A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability
	Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse2021

First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young
	Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products2020

Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy
	Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products
	Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making
	Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility
	Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-192019

Assessing effects of drugs in wastewater on aquatic wildlife
	New FDA Study Shines Light on Sunscreen Absorption
	A Novel Mouse Model Offers Insights About Hypersensitivity to an HIV Drug
	New Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention2018

CDER Scientists Investigate Critical Cellular Functions That Can Be Targeted to Kill Cancer Cells
	New Class of Drugs Fulfills Promise of RNA-based Medicine
	Advancing the Science of Nanotechnology in Drug Development
	CDER Scientists Use Modern Measurement Tools for Quality Assurance and Comparability of Complex Drugs2017

CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals
	In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine
	FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products
	Lab Tests in Rodents Suggest Potential New Biomarker for Acute Pancreatic Injury
	Novel Approach Allows Expansion of Indication for Cystic Fibrosis Drug
	Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing
	Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers

                                                                                  Content current as of:
      12/06/2023
              
              
Regulated Product(s)
		 DrugsNews & Events for Human Drugs

          
                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop