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                Center for Drug Evaluation and Research | CDER

Center for Drug Evaluation and Research | CDER
            
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
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                        Accelerating Rare disease Cures (ARC) Program
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          Center for Drug Evaluation and Research | CDER
          CDER Offices and DivisionsCenter for Drug Evaluation and Research | CDER CDER Offices and Divisions

    
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Offices

Office of the Center Director

	Patient-Focused Drug Development Program Staff
		Advisory Committee Staff
		Controlled Substances Program
		Counter-Terrorism and Emergency Coordination Staff (CTECS)
		Drug Shortages Staff
	Office of Communications

	Division of Drug Information

		FDA Pharmacy Student Experiential Program
		Division of Health Communication
		CDER Trade Press
		Division of Digital and Online Communications
		Professional Affairs and Stakeholders Engagement
	Office of Compliance

	Office of Compounding Quality and Compliance
		Office of Drug Security, Integrity and Response
		Office of Manufacturing Quality
		Office of Program and Regulatory Operations
		Office of Scientific Investigations
		Office of Unapproved Drugs and Labeling Compliance
	Office of Executive Programs
	Office of Generic Drugs

	Immediate Office
		Office of Bioequivalence
		Office of Generic Drug Policy
		Office of Regulatory Operations
		Office of Research and Standards
		Office of Safety and Clinical Evaluation
	Office of Management
	Office of Medical Policy

	Office of Medical Policy Initiatives (OMPI)
		Office of Prescription Drug Promotion Communications (OPDP)
	Office of New Drugs

	Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN)

		Division of Cardiology and Nephrology (DCN)
			Division of Diabetes, Lipid Disorders and Obesity (DDLO)
			Division of General Endocrinology (DGE)
			Division of Division of Non-malignant Hematology (DNH)
			Division of Pharm/Tox for Cardiology, Hematology, Endocrinology and Nephrology (DPT-CHEN)
		Office of Drug Evaluation Sciences

		Division of Clinical Outcome Assessment (DCOA)

			Clinical Outcome Assessment (COA) Program Overview
				Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
			Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD)

			Biomarker Qualification Program (BQP)
				Biomedical Informatics and Regulatory Review Science (BIRRS)
				OND Regulatory Science Research Program
			Digital Health Technology
			Drug Trials Snapshot
		Office of Immunology and Inflammation (OII)
		Division of Dermatology and Dentistry (DDD)
			Division of Gastroenterology (DG)
			Division of Hepatology and Nutrition (DHN)
			Division of Pulmonology, Allergy and Critical Care (DPACC)
			Division of Rheumatology and Transplant Medicine (DRTM)
			Division of Pharm/Tox for Immunology and Inflammation (DPT-II)
		Office of Infectious Diseases (OID)
		Division of Anti-infectives (DAI)
			Division of Antivirals (DAV)
			Division of Pharm/Tox for Infectious Diseases (DPT-ID)
		Office of Neuroscience (ON)
		Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
			Division of Neurology I (DN I)
			Division of Neurology II (DN II)
			Division of Pharm/Tox for Neuroscience (DPT-N)
			Division of Psychiatry (DP)
		Office of New Drugs Regulatory Science Research
		Office of Nonprescription Drugs (ONPD)
		Division of Nonprescription Drugs I (DNPD I)
			Division of Nonprescription Drugs II (DNPD II)
		Office of Oncologic Diseases (OOD)
		Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
		Division of Pediatrics and Maternal Health (DPMH)
			Division of Rare Diseases and Medical Genetics (DRDMG)
			Division of Urology, Obstetrics, and Gynecology (DUOG)
			Division of Pharm/Tox for Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (DPT-RPRUMI)
		Office of Specialty Medicine (OSM)
		Division of Imaging and Radiation Medicine (DIRM)
			Division of Ophthalmology (DO)
		Office of Therapeutic Biologics and Biosimilars (OTBB)
		Clinical Outcome Assessments (COA) Staff
		Labeling Policy Team
	Office of Pharmaceutical Quality (OPQ)

	Office of Policy for Pharmaceutical Quality
		Office of Quality Surveillance
		Office of Pharmaceutical Quality Research
		Office of Quality Assurance
		Office of Program and Regulatory Operations
		Office of Product Quality Assessment I
		Office of Product Quality Assessment II
		Office of Product Quality Assessment III
		Office of Pharmaceutical Manufacturing Assessment
	Office of Regulatory Policy
	Office of Strategic Programs

	Office of Program and Strategic Analysis
		Office of Business Informatics
	Office of Surveillance and Epidemiology
	Office of Translational Sciences

	Office of Biostatistics
		Office of Clinical Pharmacology
		Division of Applied Regulatory Science
			Division of Pharmacometrics
			Genomics and Targeted Therapy Group
			Division of Translational and Precision Medicine (DTPM)
		Office of Computational Science
		Office of Study Integrity and Surveillance

                                                                                  Content current as of:
      01/16/2024Center for Drug Evaluation and Research | CDER
            
          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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