United States (US) Food and Drug Administration (FDA) – Introduction

USA – United States of America

The United States of America (USA) commonly referred to as the United States (U.S.) or America, is a federal republic consisting of 50 states and a federal district.

The 48 contiguous United States are:

  • Alabama
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming

The state of Alaska is located in the northwestern part of North America and the state of Hawaii is an archipelago in the mid-Pacific.

The Federal District is Washington D.C.

Food and Drug Administration (FDA)

FDA is Food and Drug Administration headquarters located at New Hampshire Ave Silver Spring, MD.

Responsibilities:

FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

FDA is responsible for

  • Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
  • Protecting the public from electronic product radiation
  • Assuring cosmetics and dietary supplements are safe and properly labeled
  • Regulating tobacco products
  • Advancing the public health by helping to speed product innovations

Constitution:

The Food and Drug Administration (FDA) is organized into eight (8) office centers.

  1. CDER: Center for Drug Evaluation and Research
  2. CBER: Center for Biologics Evaluation and Research
  3. CDRH: Center for Devices and Radiological Health
  4. CFSAN: Center for Food Safety and Applied Nutrition
  5. CVM: Center for Veterinary Medicine
  6. NCTR: National Center for Toxicological Research,
  7. OC: Office of the Commissioner
  8. ORA: Office of Regulatory Affairs

The Office of Regulatory Affairs is considered the “eyes and ears” of the agency, conducting the vast majority of the FDA’s work in the field. 

DISTINCT LEGAL PROCEDURES FOR APPROVAL OF A MEDICINAL PRODUCT

The framework has three (3) sections:

  • Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • FDA regulations
  • FDA guidance

Federal Food, Drug, and Cosmetic Act (FD&C Act)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal framework within which FDA operates. The FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.

FDA Regulations

FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations.

This typically involves a process known as “notice and comment rulemaking” that allows for public input on a proposed regulation before FDA issues a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).

FDA Guidance

FDA follows the procedures required by its “Good Guidance Practice” regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The Good Guidance Practice regulation can be found at 21 CFR 10.115.

Related Articles

Important and Useful FDA links

Home http://www.fda.gov/ CFR http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm Orange book http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm BMIS http://www.accessdata.fda.gov/scripts/cder/bmis/index.cfm Clinical Investigator Search http://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm Dissolution Database http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm Drug Establishment Registration http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm Drug Shortages http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm…

FDA DATABASES

  FDA Acronyms & Abbreviations It provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities. Approved Risk Evaluation…

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