Glossary of Acronyms and Abbreviations

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AERS: Adverse Event Reporting System

AI: Additional Information Letter

ANADA: Abbreviated New Animal Drug Application

ANDA: Abbreviated New Drug Application

BLA: Biologics Licensing Application

BPCA: Best Pharmaceuticals for Children Act

CBP: United States Customs and Border Protection

CBER: Center for Biologics Evaluation and Research

CDER: Center for Drug Evaluation and Research

CMC: Chemistry, Manufacturing, and Controls

DDMAC: Division of Drug Marketing, Advertising, and Communications

DOJ: Department of Justice

EIR: Establishment Inspection Report

EMA: European Medicines Agency

FDA: Food and Drug Administration

FDAAA: Food and Drug Administration Amendments Act

FDCA: Federal Food, Drug, and Cosmetic Act

FOIA: Freedom of Information Act

HHS: Department of Health and Human Services

ICMJE: International Committee of Medical Journal Editors

ICSR: Individual Case Study Report

IDE: Investigational Device Exemption

INAD: Investigational New Animal Drug

IND: Investigational New Drug Application

IRB: Institutional Review Board

JAMA: Journal of the American Medical Association

MAUDE: Manufacturer and User Facility Device Experience

MDR: Mandatory Medical Device Reporting

NADA: New Animal Drug Application

NAI: No Action Indicated

NDA: New Drug Application

NCIE: Notice of Claimed Investigational Exemption for a New Animal Drug

NEJM: New England Journal of Medicine

NIH: National Institutes of Health

NLM: National Library of Medicine

NSE: Not substantially equivalent

OAI: Office Action Indicated

ORA: Office of Regulatory Affairs

OTC: Over-the-counter

PhRMA: Pharmaceutical Research and Manufacturers of America

PMA: Premarket Approval Application

PREA: Pediatric Research Equity Act

SEC: Securities and Exchange Commission

VAERS: Vaccine Adverse Event Reporting System

VAI: Voluntary Action Indicated