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          Regulatory Pharmaceutical Fellowship ProgramCenter for Drug Evaluation and Research | CDER Regulatory Pharmaceutical Fellowship Program
  
  	
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The U.S. Food and Drug Administration (FDA) partners with universities and colleges of pharmacy in the United States to offer FDA-affiliated fellowship programs to Doctor of Pharmacy graduates in several specialties. The purpose of the Regulatory Pharmaceutical Fellowship program is to train selected candidates in one of six tracks focused on drug information, medication safety, regulatory advertising & promotion, regulatory affairs and policy, biopharmaceutical manufacturing, or regulatory science. The program provides participants with the unique opportunity to learn from mentors in their chosen specialty track across three diverse settings in government, academia, and industry. Graduates of the fellowship program are qualified to pursue careers in any of the three practice settings.

**Recruitment opening for 2024-2026 positions on a rolling basis. See program specific information below for important dates and links to more information.**

Biopharmaceutical Manufacturing - not recruiting
	Biopharmaceutical Manufacturing – Not recruiting for the 2024-2026 cycle

Two-Year Biopharmaceutical Manufacturing Fellowship provided by Albany College of Pharmacy and Health Sciences

Fellowship dates: N/A

Four months with the Stack Family Center for Biopharmaceutical Education and Training (CBET) at Albany College of Pharmacy and Health Sciences in Albany, NY
	Twelve months at Curia Global in global contract research, development and manufacturing at one or more locations
	Eight months at FDA in the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality in Silver Spring, MDQuestions? Contact Bernard.Tyrrell@acphs.edu.

Drug Advertising and Promotion - not recruiting
	Drug Advertising and Promotion - Not recruiting for the 2024-2026 cycle

Two-Year Regulatory Advertising and Promotion Fellowship provided by Purdue University

Fellowship dates: N/A

Six months at Purdue University in Indianapolis, IN
	Nine months at Johnson & Johnson in Titusville, NJ
	Nine months at FDA in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research in Silver Spring, MD (currently a remote work environment)Questions? Contact AdPromoFellowship@purdue.edu

Drug Information – 3 positions
	Drug Information – 1 position

Two-Year Drug Information Fellowship provided by Belmont University

Fellowship dates: June 1, 2024 – May 31, 2026

Seven months will be spent at Belmont University with practice site responsibilities in the HealthTrust Drug Information Service in Nashville, TN
	Six months will be spent at Belmont University in the Christy Houston Foundation Drug Information Center in Nashville, TN
	Five months will be spent at HealthTrust GPO Operations in Nashville, TN
	Six months will be spent at FDA in the Division of Drug Information in the Center for Drug Evaluation and Research in Silver Spring, MDBelmont Fellowship
Visit Belmont University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact druginfo@belmont.edu.

Drug Information – 2 positions

Two-Year Drug Information Fellowship provided by Purdue University

Fellowship dates: July 1, 2024 – June 30, 2026

Six months will be spent at Purdue University in Indianapolis, IN
	Twelve months will be spent at Eli Lilly & Company in Global Medical Information in Indianapolis, IN or at Janssen Scientific Affairs, LLC in Medical Information in Horsham, PA
	Six months will be spent at FDA in the Division of Drug Information in the Center for Drug Evaluation and Research in Silver Spring, MDPurdue Fellowship
Visit Purdue University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact DrugInfoFellowship@purdue.edu

Medication Safety – 3 positions
	Medication Safety – 1 position

Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University

Fellowship dates: July 1, 2024 – June 30, 2026

Four months will be spent at Butler University in Indianapolis, IN
	Twelve months will be spent at Regeneron Pharmaceuticals in Regulatory Affairs and Global Patient Safety in Tarrytown, NY
	Eight months will be spent at FDA in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MDButler Fellowship
Visit Butler University's Pharmacy Fellowship Programs Website for eligibility criteria and key application dates. Questions?  Contact rxfellowships@butler.edu

Medication Safety – 1 position

Two-Year Global Patient Safety and Pharmacovigilance Fellowship provided by Butler University

Fellowship dates: July 1, 2024 – June 30, 2026

Four months will be spent at Butler University in Indianapolis, IN
	Twelve months will be spent at Eli Lilly in Global Patient Safety in Indianapolis, IN
	Eight months will be spent at FDA in the Division of Medication Error Prevention and Analysis in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MDButler Fellowship
Visit Butler University's Pharmacy Fellowship Programs Website for eligibility criteria and key application dates. Questions?  Contact rxfellowships@butler.edu

Medication Safety – 1 position

Two-Year Medication Safety Fellowship provided by Purdue University

Fellowship dates: July 1, 2024– June 30, 2026

Four months will be spent at Purdue University in Indianapolis, IN
	Twelve months will be spent at AbbVie in Pharmacovigilance and Patient Safety in North Chicago, IL
	Eight months will be spent at FDA in the Division of Risk Management in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MDPurdue Fellowship 1 Position
Visit Purdue University's Medication Safety Fellowship for eligibility criteria and key application dates. Questions? Contact MedSafetyFellowship@purdue.edu

Medication Safety – Not recruiting for the 2024-2026 cycle

Two-Year Risk Management Fellowship provided by Rutgers University

Fellowship dates: N/A

A longitudinal academic experience provided by Rutgers University in Piscataway, NJ with travel expected to the campus at least once monthly throughout the program
	Twelve months at Pfizer in the Risk Management Center of Excellence in Collegeville, PA
	Twelve months at FDA the Division of Risk Mitigation Assessment and Medication Error Surveillance, in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MDQuestions? Contact Carolyn.Seyss@pharmacy.rutgers.edu

Regulatory Policy – TBA
	Regulatory Policy and Program Management –TBA

Two-Year Regulatory Policy and Program Management Fellowship provided by Howard University

Fellowship dates: TBA

A longitudinal academic experience provided by Howard University in Washington, DC with travel expected to campus for predetermined instruction and development focused on the drug development process and its requisite policy
	Eighteen months at Genentech in a rotational immersion in regulatory policy and program management in Washington, DC (travel expected as needed to the San Francisco Headquarters)
	Six months at FDA in the Office of Medical Policy in Silver Spring, MDQuestions? Contact Earl.Ettienne@Howard.edu

Global Regulatory Affairs and Policy – TBA

Two-Year Regulatory Affairs and Policy Fellowship provided by Howard University

Fellowship dates: TBA

Six-month longitudinal academic experience at Howard University in Washington, DC with an emphasis on mastering research design and methodology, and understanding legislation and regulation. Fellows will have an opportunity to earn certificates in Teaching, Regulatory Writing, and Regulatory Affairs (RAC).
	Twelve months at GlaxoSmithKline in a rotational immersion in regulatory advertising and promotion, strategy, and policy and intelligence.
	Six months at FDA in the Office of Medical Policy in Silver Spring, MD focused in either patient labeling or regulatory policyQuestions? Contact Earl.Ettienne@Howard.edu

Regulatory Science – not recruiting
	Regulatory Science – Not recruiting for the 2024-2026 cycle

Two-Year Regulatory Science Fellowship provided by Rutgers University

Fellowship dates: N/A

Eight months will be spent in a clinical rotation experience, provided by Rutgers University Ernest Mario School of Pharmacy in Piscataway, NJ at an associated clinical practice site
	Eight months will be spent at Sanofi in regulatory strategy exposure in the Regulatory Affairs North American organization in Bridgewater, NJ (travel expected as needed to the site)
	Eight months will be spent at FDA in the Division of Pediatrics and Maternal Health in the Office of New Drugs in Silver Spring, MDQuestions? Contact Carolyn.Seyss@pharmacy.rutgers.edu

For questions about FDA-Affiliated Pharmacy Fellowship Programs that cannot be addressed directly to a specific program above, contact FDA’s Division of Drug Information at pharmacy.fellowships@fda.hhs.gov.

                                                                                  Content current as of:
      10/30/2023
              
              
Regulated Product(s)
		 DrugsCenter 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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