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Structured Product Labeling Resources
SPL Update - July 2006
Download Labels from NLM website
New Requirements for Prescribing Information
27th June 2006
SPL Standard for Content of Labeling Technical Questions and Answers
8th December 2005
SPL Release 3 Implementation Guide for FDA Content of Labeling v0.9
28th July 2006
FDA SPL stylesheet
24th July 2006
SPL Release 2 Implementation Guide for Highlights
10th May 2006
Companion Document for SPL Implementation, Version 2
16th May 2006
FDA SPL Schema for Implementation
23rd March 2006
Highlights Text and Data Elements in Structured Product Labeling
25th January 2006
21 CFR Parts 201, 314, and 601 Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products and Draft Guidances and Two Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule and Notices
25th January 2006
SPL Implementation Guide
12th January 2006
ELIPS Validation and Conformance Rules
12th January 2006
FDA SPL Data Elements Examples
30th December 2005
Guidance for Industry SPL Standard for Content of Labeling - Technical Qs & As
13th December 2005
FDA SPL 2a Schema stylesheet
18th November 2005
Guidance for Industry Providing Regulatory Submissions in Electronic Format — Content of Labeling
20th April 2005
SPL Data Standards
Route of administration
Dosage form
Package type
Potency
Color
Shape
Coating
Size
Scoring
Imprint Codes
Symbols
SPL DEA Schedule
Section Headings (LOINC)
Code System Object Identifiers
Code system object identifiers (OIDs)
Pharmacological Class - Physiologic Effect
Pharmacological Class - Mechanism of Action
Pharmacological Class - Structural Class
Intent of Use
Precondition Categories
Lab Test
Race
Sex
Contributing Factor - General
Type of Consequence
Pharmacokinetic Effect
Medical Condition
Content of Labeling Type
Limitation of Use
Time
Indication Category
Substances/Unique Ingredient Identifiers (UNIIs)
UCUM Codes
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