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post Jul 25 2006, 02:23 PM
FDAPetitions.com
Questions and Answers

What is FDAPetitions.com?

FDAPetitions.com is a website that contains research on Citizen Petitions filed with the US Food and Drug Administration. It is a publication of Parry Ashford Inc., Miami, FL, USA.

So, FDAPetitions.com contains all of the petitions?

No. The database includes petitions filed after January 1, 2004. It focuses on petitions filed regarding prescription pharmaceutical products. It does not include petitions regarding OTC products, medical devices, animal products, food, laser light shows, etc. For complete information on research criteria, see the Research Criteria Topic.

What does FDAPetitions.com do or tell me Regulations.gov doesn't?

There are three primary differences between FDAPetitions.com and the FDA regulations site.

First, FDAPetitions.com categorizes and sorts all of the petitions, so they are easy to find either by browsing or by using the search feature. There are two sections, Current Petitions and an Archives which includes those petitions that FDA has taken a final action. Subcategories include Product Petitions, Suitability Petitions, Safety Petitions, and Issue Petitions that deal with broader topics. For example, say you are interested in a certain product, you can check the product's topic and see all of the petitions filed on it, including summaries of the petition and responses, so you don't have to read them all if you just need the quick summary. You can browse each category, or use the search feature by product name, issue, or petition number.

Second, all of the Petitions are summarized along with responses. This enables you to click on a topic, and within a few minutes read, you can understand what the Petition is asking for, the basis of its requests, and any responses to it. You can also download the filings if you need to read it.

Third, FDAPetitions.com includes analysis of petitions filed. There are several reports that answer research questions such as "how long does the average petition take before FDA action?"

Does it have a Search Feature?

Yes. There are several ways to search for petitions in FDAPetitions.com. The search engine uses a word search feature, so you can type in the name of a drug, the petition number (if you know it), or other word such as a company name and find what you need. The Search Feature is pretty intuitive, but we also have a "How to Search" video on the site that you can watch. The nice thing about the lay-out of FDAPetitions.com is that you can also browse topics -- what has been filed might surprise you.

What downloads are available?

The downloads to all of the petitions, responses, and FDA Actions are available. It is important to note that the FDA posts on its site most everything that gets filed, but not everything. We will request copies of the items not posted on the site. The downloads, of course, are free with the subscription. However, we do not include downloads of attachments. A few petitions might contain several (sometimes dozens) of attachments which we do not include. If you need them, all you need to do is check with Regulations.gov for the full docket. We also do not include a download of the "Acknowledgement Letter" -- this letter is sent after a Petition is first received, acknowledging receipt and assigning it a number. As it does not contain substantive matter, we chose not to include it. Sometimes citizens will respond to a petition by emailing a few thoughts. While we note these in the summaries, we do not include downloads to them.

Does FDA endorse FDAPetitions.com?

No. FDAPetitions.com is an independent research site.

How do you know all of the petitions, according to the research criteria, are in FDAPetitions.com?

Well, we expect that we have nearly all of the information per our research protocol, representing the universe. However, in reality, it is impossible to know whether FDAPetitions.com captures everything. But here is our methodology. We check each daily entry on the Dockets Management site; identify the petitions that meet the criteria; then follow the petition number until FDA takes action on it and it closes. We also use two cross-reference techniques to validate the research. Using this methodology, this should yield the universe of petitions.

However, we have been doing research long enough to know that there are human beings in the process so while we strive for perfection, perfection may not be reachable. For example, a company filing to response to a petition might type in the wrong docket number so it gets filed in the wrong docket; the Dockets Management branch might omit or misfile something; and we could make a research error (we are not magical nor posess mystical powers, we are researchers.) The FDA assigns over 500 docket numbers a year, so there is room for something to go wrong. Given this, we figure that FDAPetitions.com captures and represents the universe of these petitions, but it would not shock us if there is a petition or response out there not included. Given our experience, we expect an error and omission rate of less than 1%. Or as we like to say, "we are 100% certain we have 98% of the universe of information, and 98% certain that we have 100%."

In addition, our information comes from the FDA site as well as the US PTO site. If you visit them, they are quick to point out that there is no guaranty that they contain all of the information. So, we cannot possibly make a guaranty on that, either.

How often is the information updated?

The basic data is updated once a week. But note also that downloads may not be available from FDA for 1-2 months after the records are noted in the Dailies.

How much does it cost? Can I have a trial subscription

Subscriptions are sold on an annual basis, based on a per person license. Contact us directly for price information at info@fdapetitions.com. We do not offer trial subscriptions. However, when you contact us, we will direct you to a brief video tour that will show you the site.

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