US Food and Drug Administration FDA Certification profile
 

The United States FoodandDrug Administration (FoodandDrug Administration), under the United States Department of Health, Education and Welfare, is responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies. FDA consists of drug Bureau, Food Bureau, Veterinary Drug Bureau, Radiological Health Bureau, biological products Bureau, medical devices and diagnostic supplies Bureau and national Toxicology research Center, regional work management agencies, that is, 6 bureaus (some publications are also called 6 centers), a center and a regional management agency. The United States Food and drug Administration has a total staff of about 7,500 people, and the FDA headquarters has 1,143 people, including 350 people in the drug bureau.

 

The Drug Bureau (also known as the Drug evaluation and Research Center) responsible for the approval of drugs, with 8 departments and several departments.

 

1. Drug Administration Department: It consists of four departments: drug information, information system design, administrative management and budget, and medical library.

 

2, Drug supervision office: under the drug quality evaluation, drug label supervision, production and product quality, scientific research investigation, regulations and other 7 departments.

 

3. Drug Standards Department: There are 2 departments of commonly used drug evaluation, drug listing and advertising.

 

4, Drug evaluation: under the cardiovascular -- kidney drugs, anti-tumor drugs, nutrition drugs, medical imaging surgery and dental drugs, gastrointestinal drugs and coagulation drugs 5 departments.

 

5, drug evaluation two: under the anti-infective drugs, metabolism and endocrine drugs, antiviral drugs 3 departments.

 

6. Department of Epidemiology and Biostatistics: It consists of 2 departments of epidemiology and investigation and biostatistics.

 

7. Research Department: It consists of two departments: research and testing and drug analysis.

 

8. Department of Generic Drugs: There are two departments of generic drugs and bioequivalence.

 

The U.S. Food and Drug Administration is based in Washington, D.C., and Rockwell, Maryland, and has a large organization with branches all over the country. To strengthen drug quality control, the FDA divided the country into six regions, The Pacific Region (San Francisco, Seattle, Los Angeles), Southwest Region (Dallas, Denver, Kansas), Central West Region (Chicago, Minneapolis, Detroit), Northeast Region (Boston, New York, Buffalo), Mid-Atlantic Region (Philadelphia, Cincinnati, Newark, Baltimore), Southeast Region (Atlanta, Nashville, New Orleans, Orlando, Bordo) St. Gian of Lycol). Each district has a regional office, under which a number of regional offices are set up. The regional seat of the Pacific region is San Francisco, the regional seat of the Southwest region is Dallas, the regional seat of the Central West Region is Chicago, the regional seat of the Northeast region is Boston, the regional seat of the Mid-Atlantic region is Philadelphia, and the regional seat of the Southeast region is Atlanta.

 

The district office is responsible for the supervision and inspection of food, drugs, cosmetics, instruments and blood banks in the district. A number of workstations are set up in each area according to the work needs to ensure that the working face can cover the area. There are currently 143 workstations in the United States. Regional offices, regional offices, and workstations are directly under FDA at all levels. The size of the district depends on the workload, more than 65% of the drugs in the United States are produced in the Mid-Atlantic region, so the strength of the area is strong, a total of 525 employees, including 250 supervisors, accounting for about 1/4 of the supervisors at FDA headquarters, and 150 analysis and inspection personnel.

 

The administration of drugs in each state is carried out in accordance with local drug administration laws and regulations, and the main work is: testing and registration of pharmacists, supervision and inspection of drug distribution departments and pharmacies, issuing or renewing licenses, revoking licenses of illegal enterprises, evaluating local pharmaceutical colleges, and reviewing trainee pharmacies.

 

Note: The FDA is an enforcement agency, not a service agency. If someone says they are a certified laboratory under the FDA, then he is misleading the consumer at the very least, because the FDA is not part of the public service certification bodies and laboratories, and there is no so-called "FDA". Designated laboratory "; The FDA, as a federal law enforcement agency, cannot engage in this kind of officiating and playing sports. FDA will only certify the GMP quality of service testing laboratories, and will not issue certificates to the public. Specify" Or recommend a particular one or several because it is contrary to the principle of fair competition in American society.