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> Research Criteria and Methodology
post Jul 21 2006, 01:02 PM
Research Criteria for FDAPetitions.com

FDAPetitions.com is a research site dedicated to mining, tracking, and analyzing Citizen's Petitions filed with the US Food and Drug Administration. The FDA covers a large area of activities and topics, so it is essential that you understand what is included in FDAPetitions.com and what is not.

FDAPetitions.com focuses on pharmaceutical products and includes petitions filed regarding:

1. Pharmaceutical products such as a request by a brand company to alter bioequivalence standards.
2. Issues affecting the industry such as authorized generics or approval for biogenerics (or "follow on proteins").
3. Suitability petitions for the acceptance of ANDA's that are slightly different than the reference list drug.
4. Petitions regarding Safety -- that is, whether a product was removed from the market for safety reasons.

FDAPetitions.com captures petitions categorized by the FDA as "A" - Advisory Petition and "P" -- Citizen Petition.

FDAPetitions.com does NOT cover or include petitions filed regarding:
  • Food
  • Medical Devices
  • Biologics
  • Imaging Drugs
  • Blood Products
  • Over the Counter Medications
  • Radiation Emissions (such as laser light shows)
  • Vitamins
It also does not include other types of FDA filings such as notices and draft guidances. We also do not include petitions that are filed by citizens that are unpublished by FDA. These typically start in the form of an email and are not supported by data. Since January 1, 2004, only about 3 of these have been filed.

Research Methodology

The start date of the database is January 1, 2004. The methodology is to check each daily entry as listed by the Dockets Management Branch of the FDA and capture those petitions meeting the criteria above as well as all responses and FDA actions submitted under the petition number. We follow the petition from the initial filing to final FDA action or withdrawal from the petitioner. These data from the "FDA Dailies" are then cross-referenced with the FDA Chronological List and also the FDA annual docket. In January 2008, FDA began a transition to Regulations.gov, and no longer updates its Dailies section. Since that time, we have used Regulations.gov to search Dockets and Documents.

The database is updated usually every day, but, at the most, once a week. Entries are made when the data is available on-line. However, if FDA does not publish the docket entry on-line after 2-3 weeks, we will obtain copies of these documents directly. However, we do make some judgment regarding insignificant filings (a response of a consumer, the fifth reply of a petitioner, eg) and will typically not obtain copies of these.

For additional information and details, check the Q&A Section.

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