SPL Resources/Links
Below you will find a list of common acronyms used in drug labeling and listing, as well as links to related web pages. We hope these resources will be helpful in understanding drug labeling and listing in the United States.
|
Common Acronyms |
|
|---|---|
| CBER | Center for Biologics Evaluation and Research |
| CDER | Center for Drug Evaluation and Research |
| CDRH | Center for Devices and Radiological Health |
| CVM | Center for Veterinary Medicine |
| CoL | Content of Labeling |
| DDMAC | Division of Drug Marketing, Advertising and Communications |
| D-U-N-S® | Data Universal Numbering System by Dun & Bradstreet |
| eDRL | Electronic Drug (Establishment) Registration and (Product) Listing |
| ESG | Electronic Submissions Gateway |
| FDA | U.S. Food and Drug Administration |
| FDAAA | FDA Amendments Act |
| FEI | FDA Establishment Identifier (Registration Number) |
| FPI | Full Prescribing Information |
| GUID | Global Unique Identifier |
| PI | Package Insert (also referred to as “USPI”) or Product Information |
| PDP | Principal Display Panel |
| PLR | Physician Labeling Rule (also referred to as SPL PLR) |
| SPL | Structured Product Labeling |
| UDI | Unique Device Identifier |
| USPI | U.S. Package Insert |
| XML | eXtensible Markup Language |
| FDA Resources | |
|---|---|
| Drugs@FDA | FDA Approved Drug Products |
| FDA Contacts | Email address for sending inquiries about SPL |
| FDA Data Standards | Sign up for email updates and learn about SPL, etc. |
|
FDA Electronic Submissions Gateway |
Set up an ESG Account |
| FDA SPL Index Guidance | FDA Final Guidance - PDF format |
| FDA SPL PLR Final Rule | FDA CDER Final Rule (21 CFR Parts 201, 314, and 601) - PDF format |
| FDA SPL Resources | Website featuring Guidance for Industry, Implementation Guides, Schema & Stylesheet, Resource Links, etc.) |
|
Additional Resources |
|
|---|---|
| Dun & Bradstreet | FDA DUNS number requests |
| LabelDataPlus | Reed Tech’s drug label database for Veterinary/Animal Health Drugs |
| NLM DailyMed Website | View or download published SPLs |
| PDR3D |
The PDR Network Digital Drug Database for Human Health labels, created in collaboration with Reed Technology. |
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