A: While any person can file a FOIA request, it frequently makes more sense to have FOI Services process the request. First, FOI Services offers convenience. FOI Services has filed over 100,000 FOIA requests…we know exactly how a request should be phrased, where to submit a request, and lots of other knowledge born of long experience. We often already have exactly the document you need…saving you weeks of waiting. FOI Services also keeps all requests confidential. Every request submitted to the Federal government is a matter of public record. When FOI Services requests a document, no one knows that you initiated a request… allowing you to keep your research projects confidential.
A: FOI Services does not process FOIA requests for information about private (non-government) individuals, nor do we process requests of a personal nature, as they are subject to the provisions of The Privacy Act, and must be signed by the individual in question. If you would like to request this information yourself, a list of government FOI addresses is available at: http://www.usdoj.gov/foia
A: If FOI Services has the document you need, it can can be downloaded immediately. If the document you need must be ordered from the FDA turnaround time depends on the type of information requested. Some documents are available within a few weeks. Device Premarket Notifications [510(k)s] have the longest fulfillment time, typically 18-24 months.
A: If you're requesting a FOIA document for the first time you might be surprised by its appearance…unlike monographs and journal article reprints, these documents don't contain neat titles, abstracts, publication date and source, and other familiar hallmarks of the literature. The documents you receive were not prepared for publication, and are simply photocopies of correspondence, reviewers notes, handwritten observations, etc. They may be purged of confidential content with broad swipes of black ink. In the case of microfiche, material is withheld by physically cutting it off the film. That said, while these documents may not look attractive, they provide a wealth of information unattainable elsewhere. Samples of many document types are available at Document Descriptions.
A: Each record at FOI Services is indexed to create a short indexing description; when you use the main search box you search the document description only. When you use the full-text search box, you will be searching the words used in the document itself, and will cover only those records related to FDA inspections.
A: Use the searching skills you already have!
A: Over 40,000 inspection reports and related documentation are full-text searchable. Not every inspectional document is suitable for creating a record which can be read by the computer – the record may be handwritten (e.g., some 483s), heavily redacted, or otherwise illegible for the OCR conversion.
A: Put the document in your cart and follow the on-screen directions. You can use one cart to order documents found in the main search box and documents located in full-text searching.
A: No, full-text searching is intended as an aid to help you find appropriate documents. The document you download will be an image PDF, just as if it had been identified in the main search box. Why? We promise that the document you download is a faithful reproduction of the information provided by the government, and our records have been admitted into courts in the US and overseas. The OCR conversion process may strip out formatting, introduce small errors (e.g., from an illegible phrase), and does not include information such as charts, drawings, handwritten records and other non-machine readable material. Curious? Here's a sample.
A: Each product name search is $449 for the FAERS database (8/28/2012-6/30/18). There is an additional $449 fee for a search of the older databases [Adverse Event Reporting System (AERS 11/1/1997-8/27/2012), and Spontaneous Reporting System (SRS 1/1/1969-10/31/1997)].
A: Just as FDA does, we search FDA's FAERS, AERS, and SRS databases. The difference is that, with one of our searches, the results are presented in a user-friendly format. Instead of paper printouts containing line listings of reports, you will receive a zip file containing a custom Microsoft Access database which allows you to manipulate the data in a variety of ways (filters and exporting are two examples).
A: FDA's formal tracking of adverse event reports started with the SRS database in 1969. Since we are searching the FDA data, our searches may go back that far, depending on drug approval date.
A: The portion of the FDA records that we have access to currently goes through December 31, 2017. When new quarterly updates to the data become available, we work as quickly as possible to add these to our searches.
A: Searches with narrowed criteria are possible, but may be problematic because of the format of the original data. If you are interested in having us run a search of this nature, please contact one of our information specialists at 301-975-9400 or firstname.lastname@example.org so we may discuss your specific needs. Very specialized searches may involve additional charges. Another option is to obtain a complete set of records for the product in question and use the filters included in your data to view reports by reaction type, outcome, or suspect status. Reports detailing reaction summaries and outcome summaries can also be created by the click of a button.
A: Due to the nature of FDA’s data, we do not recommend attempting to search for specific years. For various reasons, a date is not always recorded for each event report, making a date-specific search potentially incomplete. It’s recommended that you obtain a complete set of records for your desired product; you can then scan the results for the event date (where available) in records of interest.
A: Generally, both the trade name and generic name for a product will be listed in a report. However, there are a number of records where only one name was listed at the time the report was made to FDA. For this reason, it is recommended that both the trade and generic names be searched; this helps to ensure you don’t miss out on potentially valuable records.
A: Our search results are presented as a custom Microsoft Access database. They will run on computers with Microsoft Access version 2000 or higher.
A: Redacted copies (copies purged of confidential patient and reporter identifying information) of the original Medwatch forms are available from FDA via a Freedom of Information Act (FOIA) request. You’ll need the Individual Safety Report (ISR) number (for AERS records) or Case ID (for FAERS records) for each report you’d like to see (ISR and/or case numbers are included in your custom database). FOI Services can place the FOIA request for Medwatch forms on your behalf; just call or email to have one of our Information Specialists assist you.
A: Click here to download a sample result set.