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How To Get The Information You Need From FDAFDA is a large bureaucracy employing thousands of people all over the nation. It can at times be difficult to figure out how to locate all the information you need. There are several sources available for FDA information, and which one you use depends on what type of information you need. Choose from the following list of categories: General Information General InformationFor general information, the best sources are the FDA Web Site or your local district FDA office. FDA Web SiteThe FDA web site allows you to browse at your own pace, as well as search to find specific information. It is divided into industry and topic subsections, so that related information from any given industry is easy to find. The following topics are addressed: FDA News, Biologics, Cosmetics, Foods, Medical Devices and Radiological Health, Human Drugs, Animal Drugs, International Operations, Medical Device Reporting, Field Operations and Imports, Toxicology, and Children and Tobacco. Each of these sections then has a tremendous amount of information including guidelines, information on organizational structure, and new developments. Additionally, FDA's home page has a choice entitled "More Choices" which contain miscellaneous information including forms, consumer information, special interest topics, history, and much more. FDA District OfficesFDA staffs district offices in many cities throughout the country. These offices report to the agency through the Office of Regulatory Affairs, and they are responsible for conducting inspections, and helping manufacturers. If you can't find a document that you need on line, your district office can direct you to the proper source for the information. Copies of Laws, Regulations, and Guidance DocumentsThe GMP Institute provides pocket sized copies of the GMP regulations. This small size allows you to provide a convenient method for all employees to have a means for being familiar with the GMP regulation. Click here for more information. Other regulations and all laws can be obtained through the Government Printing Office (GPO) either on line, or via a telephone or mail request. Regulations are printed as part of the Code of Federal Regulations, which is available electronically on line or in hard copy through the GPO. The CFR is updated every year as of April 1. Updates of regulations and other actions taken by FDA are published in the Federal Register, which is a daily publication. For more information on the Federal Register, read The Federal Register - What It Is and How To Use It. The Federal Food Drug and Cosmetic Act is also available on line. To learn about the availability and prices of printed materials from the Government Printing Office, they have a helpful fax on demand system, which can be contacted at 202-512-1716. If you wish to place an order for a hard copy of any part of the CFR or the laws, the GPO can be contacted at the following address:
Phone orders must be paid with a Visa, MasterCard, or Superintendent of Documents deposit accounts. Mail orders must include a check or money order. FDA is in the process of overhauling its system for distributing guidance documents. Most are available at http://www.fda.gov/opacom/morechoices/industry/guidedc.htm. If you are unable to locate the document you need at this site, contact your local district office. Freedom of Information Act RequestsInformation that was not specifically prepared for public distribution can sometimes be obtained under the Freedom of Information Act. One particularly interesting type of information you can obtain here is 483's, Establishment Inspection Reports, and Warning Letters issued by FDA. Some companies prefer to obtain these records through third parties, so as to remain anonymous. A fee is usually charged for the time spent researching and for the copying involved in fulfilling an FOI request. FDA's web site has several FOI Reading Rooms. They can be found at the following links:
If the information you seek is not found on any of these pages, mail your request to the following address:
In your request, be sure to include your name, telephone number, address, a specific description of the records you want, and information on your willingness to pay the fee, including any limits on how much you are able to spend. Separate requests must be submitted for each different set of information desired. Information Regarding a Specific Situation in Your PlantIf you have questions regarding a specific situation at your plant, there are several sources of information you should explore. FDA offers an industry assistance portal for all products it regulates. It can be found at http://www.fda.gov/oc/industry/default.htm . A second source of information for a specific problem is your local FDA District Office. We recommend getting to know the people there, as they are your closest contacts. They are also the people who will be inspecting you, and a good relationship with them can work to your advantage. If you are a small business, FDA provides Small Business Representatives to assist with any general questions or problems you may have. Additionally, the publication A Small Business Guide to FDA provides important information for small businesses. However, if you need information which is highly specialized or unique to your industry, it is best to contact an FDA Center Small Business Contact. Additional InformationFor addition information on obtaining information from FDA, please read A Handbook for Requesting Information and Records from FDA. |
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