How to Apply
FDA Pharmacy Student Experiential Program (PSEP)
Eligibility Requirements
To be eligible for participation in the FDA Pharmacy Student Experiential Program, students must meet the following criteria:
- U.S. citizenship.
- Enrollment in an ACPE-accredited pharmacy school program.
- Eligibility to begin Advanced Pharmacy Practice Experience (APPE) rotations, adhering to any requirements specified by their pharmacy school.
Due to Homeland Security Presidential Directive 12 (HSPD-12) requirements for issuance of a Personal Identity Verification (PIV) card, students selected for placement with certain PSEP rotation sites must be able to successfully pass a Tier 1 background investigation. These students should expect to have fingerprints taken and submitted, as well as answer questions about where they have lived, worked, gone to school, and any military history or police records. PSEP students must be U.S. citizens and have maintained residence in the United States for at least 3 of the past 5 years.
Students are strictly prohibited from releasing, publishing, or disclosing non-public information, specifically any confidential commercial or trade secret information obtained while serving as an FDA student.
For a comprehensive and detailed list of all requirements, please refer to the Manual of Policies and Procedures (MAPP) 4410.2 – FDA Pharmacy Student Experiential Program.
Application Procedures
FDA PSEP generally accepts applications from interested students in the fall preceding their final year of pharmacy school (i.e., typically at the start of the third professional year).
Student should send their application package to their experiential coordinator for submission to the FDA's PSEP program during the application window. A complete application includes the following:
- Resume or curriculum vitae.
- A one-page essay on a regulatory issue that interests the student and why. Explain how a rotation at the FDA will support student development as a future pharmacist. In the essay, please include:
- Up to three preferred rotation sites.
- Up to three preferred rotation date blocks.
- Optional note if open to any date and rotation site
Students who are selected for placement will receive direct notification from a preceptor at FDA. Students who are not selected for placement should expect to receive notification from their experiential coordinator confirming they were not placed in a rotation block with FDA.
Rotation Sites – as of the 2027-2028 academic year
Please note: this list is subject to modification at any time based upon preceptor availability. A student may also be offered a rotation with a preceptor whose site is not listed here.
| Center/Office | Divison | Method | Location | Areas of Rotation Focus |
|---|---|---|---|---|
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Compounding Quality and Compliance (OCQC) | Division of Compounding I (DCI), Branch 3 | On-Site | Irvine, CA | Compounding Facility Inspections, Current Good Manufacturing Practices (CGMPs), Drug Manufacturer Investigations and Compliance, Drug Quality, Medical Products Laboratory (Microbiological and Chemical), Quality Assurance, Regulatory Affairs, Regulatory Guidelines (USP and others), Sterile Operations |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Response (ODSIR) | Division of Global Drug Distribution Policy (DGDDP), Import Coordination Branch (ICB) | On-Site | Silver Spring, MD | Drug Firm Shipping Histories, Import Entry Document Review, Manufacturer Information Review, Product Labeling Review, Public Health Risk Assessment, Regulatory Compliance, Regulatory Submissions Review |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Response (ODSIR) | Division of Supply Chain Integrity (DSCI), Supply Chain Security Branch (SCSB) | On-Site | Silver Spring, MD | Counterfeit Drug Prevention, Drug Supply Chain Security Act (DSCSA), Drug Supply Chain Integrity, Prescription Drug Marketing Act (PDMA), Public Health Risk Mitigation, Regulatory Enforcement, Stakeholder Engagement, Supply Chain Surveillance |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Manufacturing Quality (OMQ) | Regulatory Compliance and Accountability Staff (RCAS) | On-Site | Silver Spring, MD | GMP Compliance |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI) | Division of Enforcement and Postmarket Safety (DEPS), Compliance Evaluation Branch (CEB) | On-Site | Silver Spring, MD | Bioavailability/Bioequivalence (BA/BE) Studies, Bioresearch Monitoring (BIMO) Program, ClinicalTrials.gov Reporting and Enforcement, Compliance Evaluation, Good Clinical Practice (GCP), Inspection Evaluation and Action, Regulatory Enforcement |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drugs and Labeling Compliance (OUDLC) | Division Of Labeling, Registration, & Unapproved Drugs (DLRUD), Drug Registration & Labeling Branch (DRLB) | On-Site | Silver Spring, MD | 21 CFR Part 207 Compliance, Drug Establishment Registration, Drug Label Barcode Requirements, Drug Listing Requirements, Drug Registration and Listing System (DRLS/SPL), National Drug Code (NDC) Assignment, Section 510 of the FD&C Act, Structured Product Labeling (SPL), Supply Chain Transparency |
| Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drugs and Labeling Compliance (OUDLC) | Division of Unapproved Drugs and Labeling (DUDL), Fraud Drugs Branch (FDB) | Virtual | Remote | Fraudulent Drug Products, Regulatory Enforcement, Unapproved Drug Products |
| Center for Drug Evaluation and Research (CDER) | Office of the Center Director(OCD) | On-Site | Silver Spring, MD | Controlled Substances, Substance Use, Behavioral Health, Overdose Prevention, Patient Access Policy, Public Health Strategy |
| Center for Drug Evaluation and Research (CDER), Office of The Center Director (OCD) | Counter-Terrorism and Emergency Coordination Staff | Virtual | Remote | Medical Countermeasures for Chemical, Biological, Radiological, Nuclear, and Emerging Infectious Disease (CBRNE) Threats, Emergency Coordination, Expanded Access, and Incident Command System |
| Center for Drug Evaluation and Research (CDER), Office of The Center Director (OCD) | Drug Shortages Staff (DSS) | On-Site | Silver Spring, MD | Drug Shortage Management, Drug Shortage Mitigation, Drug Shortage Prevention, Drug Supply Monitoring, Regulatory Review of Drug Supply |
| Center for Drug Evaluation and Research (CDER) | Division of Drug Information (DDI) | On-Site | Silver Spring, MD | Adverse Event Reporting, Drug Information, Inquiry Responses, MedWatch, Small Business and Industry Assistance (SBIA) |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Bioequivalence (OB) | Division of Bioequivalence I (DBI) | On-Site | Silver Spring, MD | Bioequivalence, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Bioequivalence (OB) | Division of Bioequivalence III (DBIII) | On-Site | Silver Spring, MD | Generic Drug Products, Pediatric Drug Safety, Pharmacotherapy, Regulatory Review, Research |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Bioequivalence (OB) | Division of Bioequivalence Process Managment(DBPM) | On-Site | Silver Spring, MD | Bioavailability/Bioequivalence (BA/BE) Assessment, Generic Drug Products, Generic Drug User Fee Amendments (GDUFA), Abbreviated New Drug Application (ANDA), Controlled Correspondence, Formal Meetings, Project Management |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Regulatory Operations (ORO) | Division of Filing Review (DFR) | On-Site | Silver Spring, MD | Generic Drug Applications, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Regulatory Operations (ORO) | Division of Labeling Review (DLR) | On-Site | Silver Spring, MD | Generic Drug Products, Labeling Compliance, Prescribing Information Development, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Regulatory Operations (ORO) | Division of Project Management (DPM) | On-Site | Silver Spring, MD | Abbreviated New Drug Application (ANDA) Approval Process, Applicant Correspondence, Cross-Disciplinary Communication, Generic Drug Approval Process, Generic Drug User Fee Amendments (GDUFA), Hatch-Waxman Act, Lifecycle Management of Generic Drugs, Project Management, Regulatory Operations Review Process |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Research and Standards (ORS) | Office of Research and Standards (ORS) | On-Site | Silver Spring, MD | Generic Drug User Fee Amendments (GDUFA), Guidance Development, Regulatory Decision-Making, Complex Product Database, and Product-Specific Guidances |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Research and Standards (ORS) | Division of Therapeutic Performance II (DTPII) | On-Site | Silver Spring, MD | Bioequivalence Assessment, Oral Generic Drug Products, Pre-Application Scientific Evaluation, Product-Specific Guidance Development |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) | Office of Safety and Clinical Evaluation (OSCE) | On-Site | Silver Spring, MD | Clinical Assessment and Non-Clinical assessment of generic drugs, Drug-Device Combination Products, Generic Drug Products, Therapeutic Equivalence |
| Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office Of Safety And Clinical Evaluation (OSCE) | Division of Clinical Review (DCR) | On-Site | Silver Spring, MD | Clinical Bioavailability/Bioequivalence (BA/BE) Assessment, Clinical Perspective, Drug-Device Combination Products, Generic Drug Products, Therapeutic Equivalence |
| Center for Drug Evaluation and Research (CDER) | Division of User Fee Management (DUFM) | On-Site | Silver Spring, MD | Biosimilar User Fee Act (BsUFA), Clinical Data Assessments, Financial Management, Prescription Drug User Fee Act (PDUFA), User Fee Invoicing and Collections, User Fee Waiver Determinations |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) | Office of Medical Policy (OMP) | On-Site | Silver Spring, MD | Drug Approval Policy, Instructions for Use (IFU), Medication Guides (MG), Office of Medical Policy (OMP), Patient Labeling, Patient Package Inserts (PPI), Post-Market Surveillance Policy, Science and Technology Policy Initiatives |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP), Office of Medical Policy Initiatives (OMPI) | Division of Medical Policy Programs (DMPP) | On-Site | Silver Spring, MD | Drug Development Communication, Inclusive Policy Development, Regulatory Affairs, Regulatory Policy |
| Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP), Office of Prescription Drug Promotion (OPDP) | Division of Advertising & Promotion Review I & II (DAPRI & DAPRII) | On-Site | Silver Spring, MD | Direct-to-Consumer Advertising, FD&C Act (Drug Promotion Provisions), Healthcare Professional Promotional Materials, Labeling, OPDP Guidance Documents, Prescription Drug Advertising, Prescription Drug Promotion, Regulatory Compliance |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) | Division of Cardiology and Nephrology (DCN) | On-Site | Silver Spring, MD | Biologics License Application (BLA), New Drug Application (NDA), Post-Marketing Safety Evaluation, Pre-Marketing Safety Evaluation |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) | Division of Diabetes, Lipid Disorders, and Obesity (DDLO) | On-Site | Silver Spring, MD | Labeling Development and Review, Post-Market Safety Signal Evaluation, Risk-Benefit Assessment, Safety-Related Regulatory Actions |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Infectious Diseases (OID) | Division of Pharmacology Toxicology for Infectious Diseases (DPTID) | On-Site | Silver Spring, MD | Anti-Infective Drug Products, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Immunology and Inflammation (OII) | Division of Hepatology and Nutrition (DHN) | On-Site | Silver Spring, MD | Drug-Drug Interactions, Drug-Induced Liver Injury (DILI), Drug-Transport Interactions, In Vitro Findings, Pharmacokinetics |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) | Division of Regulatory Operations for Infectious Diseases (DROID) | On-Site | Silver Spring, MD | Anti-Infectives; Review of Pre-Investigational New Drugs (PINDs) & Investigational New Drugs (INDs), Drug Development Process, Review & Approval Process for New Drug Applications (NDAs), Biologic License Applications (BLAs), Drug Product Lifecycle Management, Project Management, and Regulatory Operations |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) | Division of Regulatory Operations for Immunology & Inflammation (DROII) | On-Site | Silver Spring, MD | Approval Process, Biologics, Biologics License Application (BLA), Biosimilars, Immunology and Inflammation, Investigational New Drug (IND) Application, New Drug Application (NDA), New Molecular Entities (NMEs), Project Management, Regulatory Affairs, Regulatory Operations, Review Process, Rheumatology and Transplant Medications |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) | Division of Regulatory Operations for Neuroscience (DRON) | On-Site | Silver Spring, MD | Analgesia (NSAIDs, Opioids), Anesthesia, Investigational New Drug (IND) Application, New Drug Application (NDA), Opioid Overdose Reversal, Project Management, Psychiatry, Regulatory Correspondence, Regulatory Operations, Regulatory Project Management, Review Timelines, Stakeholder Communication, Submission Management |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) | Division Of Regulatory Operations for Oncologic Diseases (DROOD) | On-Site | Silver Spring, MD | Approval Process, Biologics, Oncology Drug Products, Regulatory Review, Review Process |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Regulatory Operations (ORO) | Division of Regulatory Operations for Specialty Medicine (DROSM) | On-Site | Silver Spring, MD | Biologics, Clinical Studies, Investigational New Drug (IND) Application, Marketing Applications, Office of New Drugs, Regulatory Submissions, Small Molecule Drugs |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine (ORPURM) | Division of Rare Diseases and Medical Genetics (DRDMG) | On-Site | Silver Spring, MD | Drug Evaluation, Rare Diseases, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) | Office of Specialty Medicine (OSM) | On-Site | Silver Spring, MD | Bulk Drug Substances, Clinical Effectiveness Reviews, Safety Reviews |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment II (OPQAII) | Division of Product Quality Assessment IV (DPQAIV) | On-Site | Silver Spring, MD | Abbreviated New Drug Application (ANDA), Chemistry, Manufacturing, and Controls (CMC), Drug Product Quality Review, Drug Substance Quality Review, New Drug Application (NDA), Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment II (OPQAII) | Division of Product Quality Assessment XII (DPQAXII) | On-Site | Silver Spring, MD | Biopharmaceutics, Quality Control, Regulatory Review, Small Molecule Drug Product Development |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQAIII) | Division of Product Quality Assessment XVI (DPQAXVI) | On-Site | Silver Spring, MD | Biologics, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQAIII) | Division of Product Quality Assessment XVII (DPQAXVII) | On-Site | Silver Spring, MD | Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practices (CGMPs), GMP Compliance, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) | Regulatory Science Staff (RSS) | On-Site | Silver Spring, MD | AEMS Product Dictionary Maintenance, Data Management, Data Science, Drug Information Data, Drug Safety Surveillance, Pharmacovigilance Systems, Post-Marketing Safety Evaluation, Regulatory Decision-Making, Regulatory Research, Systems Modernization |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) | Project Management Staff (PMS) | On-Site | Silver Spring, MD | Regulatory Review of Drugs |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Medication Error Prevention and Risk Management (OMEPRM) | Division of Mitigation Assessment and Medication Error Surveillance (DMAMES) | On-Site | Silver Spring, MD | Drug Safety, Medication Error Prevention, Medication Error Surveillance, Pharmacovigilance, Postmarketing Safety, Risk Evaluation and Mitigation Strategy (REMS) Assessment, Risk Mitigation Strategies |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Medication Error Prevention and Risk Management (OMEPRM) | Division of Medication Error Prevention and Analysis I (DMEPAI) | On-Site | Silver Spring, MD | Proprietary Naming, Labels and Labeling, Packaging, Product Design, Human Factors, Medication Error Prevention, Postmarketing and Surveillance |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Medication Error Prevention and Risk Management (OMEPRM) | Division of Medication Error Prevention and Analysis II (DMEPAII) | On-Site | Silver Spring, MD | Human Factors, Labeling, Medication Error Prevention, Packaging Review, Post-Market Surveillance, Postmarketing Programs, Product Design, Proprietary Naming, Regulatory Review, Surveillance Methods |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Medication Error Prevention and Risk Management (OMEPRM) | Division of Risk Management (DRM) | On-Site | Silver Spring, MD | Drug Approval Process, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Pharmacovigilance and Epidemiology (OPE) | Division of Epidemiology II (DEII) | On-Site | Silver Spring, MD | Data Analysis, Drug Safety, Drug Utilization Analysis, FDA Adverse Event Reporting System (FAERS), Health Data Resources, Labeling Changes, Pharmacoepidemiology, Real-World Prescribing Patterns, Regulatory Science |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Pharmacovigilance and Epidemiology (OPE) | Division of Pharmacovigilance I (DPI) | On-Site | Silver Spring, MD | Adverse Event Data Analysis, Drug Safety, Pharmacovigilance, Postmarketing Safety Surveillance (Biologics), Postmarketing Safety Surveillance (Drugs), Public Safety Recommendations |
| Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), Office of Pharmacovigilance and Epidemiology (OPE) | Division of Pharmacovigilance II (DPII) | On-Site | Silver Spring, MD | Drug Safety, Pharmacovigilance, Postmarketing Safety |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Office of Clinical Pharmacology (OCP) | On-Site | Silver Spring, MD | Biologics and Biosimilars Development, Clinical Pharmacology, Dose Selection and Optimization, Drug Development, Maternal Clinical Pharmacology, Pediatric Clinical Pharmacology, Pediatric Drug Development, Pediatric Formulations, Regulatory Review, Research, Weight-Based Dosing |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division of Cardiometabolic and Endocrine Pharmacology (DCEP) | On-Site | Silver Spring, MD | Clinical Pharmacology, Regulatory Research, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division of Cancer Pharmacology I (DCPI) | On-Site | Silver Spring, MD | Clinical Pharmacology, Oncology Drug Products, Regulatory Review, Regulatory Science |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division of Cancer Pharmacology II (DCPII) | On-Site | Silver Spring, MD | Clinical Pharmacology, Dosage Optimization, Oncology Drug Development, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division Of Inflammation & Immune Pharmacology | On-Site | Silver Spring, MD | Biologics, Clinical Pharmacology, Drug Products, Literature Review, Public Health Research, Regulatory Review |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division of Pharmacometrics (DPM) | On-Site | Silver Spring, MD | Clinical Pharmacology, Regulatory Review, Therapeutic Proteins |
| Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) | Division of Translational and Precision Medicine (DTPM) | On-Site, Virtual | Silver Spring, MD or Remote | Biomarker-Guided Drug Development, Clinical Pharmacology, Drug Product Labeling, Drug Review Process, Pharmacogenomics, Precision Medicine, Rare Diseases, Regulatory Research, Regulatory Sciences |
| Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) | Division of Enforcement and Manufacturing (DEM) | Virtual | Remote | Consumer Protection, Regulatory and Enforcement Activities, Tobacco Products, Youth Access Prevention |
| Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) | Division of Product Compliance (DPC) | Virtual | Remote | Compliance Regulations, Enforcement Actions, Market Authorization Decisions, Pre-Market Regulatory Submissions, Project Management, Tobacco Product Market Authorization Pathways |
| Office of the Commissioner (OC) | Oncology Center of Excellence (OCE) | On-Site, Virtual | Silver Spring, MD or remote | Compassionate Use, Expanded Access, Labeling Regulations and Guidances, Oncology Labeling, Oncology Research, Oncology Therapeutics, Single Patient Expanded Access |
| Office of the Commissioner (OC), Office of Digital Transformation (ODT), Office of Data, Analytics and Research (ODAR) | Informatics Staff (IS) | On-Site | Silver Spring, MD | Health Informatics, Pharmaceutical Chemistry, Regulatory Science |
| Office of Inspections and Investigations (OII), Office of Facility, Records, and Operations (OFOR) | Division of Field Enforcement (DFE) | Virtual | Remote | Public Health Protection, Recall Operations, Regulatory Process, Recalls |
| Office of Inspections and Investigations (OII), Office Of Human And Animal Drug Inspectorate (OHADI), | Division Of Human and Animal Drug Inspectorate VI (DHADIVI) | On-Site | Irvine, CA | Current Good Manufacturing Practices (CGMPs), Drug Manufacturer Inspections and Compliance, Drug Quality, Foreign Drug Manufacturer Inspections, Generic Drug User Fee Act (GDUFA), Human and Animal Drug Products, Medical Products Laboratory (Microbiological and Chemical), Quality Assurance, Recall Operations, Regulatory Affairs, Sterile Drug Compounding |
| Office of Inspections and Investigations (OII), Office of Import Operations (OIO) | Division of Northeast Imports (DNEI) | On-Site | Silver Spring, MD | Drug Entry Review, Field Import Operations, Import Inspections, International Mail Facility, Medical Device Import Review, Regulatory Review |
| Office of Inspections and Investigations (OII), Office of Import Operations (OIO) | Division of West Coast Imports (DWCI) | On-Site | San Francisco, CA and Honolulu, HI | FD&C Act Compliance, Imported Drug Products, Regulatory Oversight |
| Office of Inspections and Investigations (OII), Office of Management (OM), Office of Workforce Management (OWM) | Executive And Scientific Resource Staff (ESRS) | On-Site | Silver Spring, MD | Commissioned Corps Management, Emergency Response, Public Health Service Mission, Regulatory Work, U.S. Public Health Service (USPHS) Commissioned Corps |
| Office of Operations (OO) | Office of FDA Commissioned Corps | On-Site | Silver Spring, MD | Commissioned Corps Management, Emergency Response, Public Health Service Mission, Regulatory Work, U.S. Public Health Service (USPHS) Commissioned Corps |
| U.S. Department of Health and Human Services (HHS), Office of Research Integrity (ORI) | Division of Education and Integrity | On-Site | Silver Spring, MD | Disease Prevention and Health Promotion, Public Health Policy and Guidance, Health Communication and Education, Infectious Disease Initiatives, Population Health Programs, and the Promotion of Trustworthy Science |