What are the offices of the FDA?
Table of Contents
What are the offices of the FDA?
Organizational structure
- Office of the Commissioner.
- Office of Operations.
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Center for Drug Evaluation and Research (CDER)
- Center for Food Safety and Applied Nutrition (CFSAN)
- Center for Tobacco Products (CTP)
Where is the FDA agency located?
FDA headquarters facilities are located in Montgomery and Prince Georges Counties in Maryland. Many FDA employees are consolidated at the White Oak Campus located in Silver Spring, MD. Remaining headquarters employees are housed in numerous additional buildings located across the Washington, D.C. area.
How do you address the FDA?
Contact FDA
- Call: 1-888-INFO-FDA. (1-888-463-6332)
- Email: See Contact FDA Centers and Offices below or search the employee directory.
- Write to: Food and Drug Administration. 10903 New Hampshire Ave. Silver Spring, MD 20993-0002.
How many FDA locations are there?
FDA is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices.
What are the 4 centers in FDA?
FDA Field Offices
- Center for Biologics Evaluation and Research.
- Center for Devices and Radiological Health.
- Center for Drug Evaluation and Research.
- Center for Tobacco Products.
What do FDA field offices do?
The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.
Is the FDA a federal agency?
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services.
Can I write to the FDA?
By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule.
How do you interact with the FDA?
How to talk to the FDA
- Prepare a detailed agenda.
- Respect their time.
- Ask specific questions.
- Be calm and respectful but not overly formal.
- Do not argue or get emotional.
- If you are not hearing what you want, ask for a meeting with management.
- Use their chain of command.
- Be patient FDA can be slow but be patient.
Who pays for the FDA?
The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.
What does the FDA approve?
The FDA approves new human drugs and biological products. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.
What does the FDA actually do?
FDA Mission The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
How do I get in touch with the FDA?
By phone:
- Call 1-888-INFO-FDA (1-888-463-6332 ).
- Call the FDA Consumer Complaint Coordinator for your state or region.
What do you report to FDA?
And if you have any reporting questions, you can call your local FDA Consumer Complaint Coordinator.
- Content current as of: 10/26/2016.
- Regulated Product(s) Animal & Veterinary. Cosmetics. Drugs. Food & Beverages. Tobacco.
What is an Interact meeting with FDA?
An INTERACT meeting enables sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase.
What is the timeframe for the FDA to respond to a protocol?
The amendment should include the investigator’s name, the qualifications to conduct the investigation, and any reference to the previously submitted protocol, if relevant. FDA should be notified within 30 days of the investigator being added.
