SPL+Indexing

**Overview**
FDA has gathered their information on SPL Indexing [|here] There is now a table that links all the active moieties to the FDA's determination of established pharmacologic class [|here].

Questions about assigned term(s): Address to SEALD@fda.hhs.gov

Notes from SPL Indexing Overview at Process / Communication Forum Feb 10 [|here].

In June 2008 FDA published the final guidance on SPL Indexing.


 * The indexing of the content of labeling for human drug and biological products using SPL (Structured Product Labeling) will be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).


 * Applicants can participate in the SPL indexing process. Having consistently and accurately indexed content of labeling is an important step toward the creation of a fully automated health information exchange system.

Tools that might be useful for further access and searching of complex terminologies such as SNOMED:


 * A [|browser from Apelon]:

A sample file of an established pharmacologic class SPL:.

SPL Resources Page containing Terminology for Indexing:

 * [|Pharmacologic Class]
 * [|Intent of Use]
 * [|Precondition Categories]
 * [|Lab Test]
 * [|Race]
 * [|Sex]
 * [|Contributing Factor - General]
 * [|Type of Consequence]
 * [|Pharmacokinetic Effect]
 * [|Medical Condition]
 * [|Limitation of Use/Issues]
 * [|Indication Category]