| Title: | New FDA Affirmations of Compliance |
|---|---|
| Date: | 2008-02-27 |
| To: | abi |
| Links: | previous, next |
THE FOOD AND DRUG ADMINISTRATION HAS DEVELOPED TWO NEW AFFIRMATION OF COMPLIANCE (AOFC) CODES FOR USE IN THE TRANSMISSION OF IMPORTED BIOLOGICAL PRODUCTS. THE CODES, THEIR TITLES, AND DESCRIPTIONS ARE PROVIDED BELOW. USE OF THESE CODES AFFIRMS THAT THE PRODUCT IDENTIFIED IN A FDA LINE MEETS THE REQUIREMENTS SPECIFIC TO THE CODE. WHILE USE OF THESE CODES IS VOLUNTARY, TRANSMISSION WILL HELP EXPEDITE THE ENTRY REVIEW PROCESS.
CODE TITLE/DESCRIPTION
STN SUBMISSION TRACKING NUMBER
THE QUALIFIER FOR THIS CODE SHOULD BE THE SUBMISSION TRACKING NUMBER ISSUED BY FDA’S CENTER FOR BIOLOGICS EVALUATION AND RESEARCH FOR THE LICENSED BIOLOGICAL PRODUCT IDENTIFIED IN THE FDA LINE. THE SUBMISSION TRACKING NUMBER IS THE BIOLOGICS LICENSE APPLICATION NUMBER.
BLN BIOLOGICS LICENSE NUMBER
THE QUALIFIIER FOR THIS CODE SHOULD BE THE FOUR DIGIT U.S. BIOLOGICS LICENSE NUMBER ISSUED BY FDA’S CENTER FOR BIOLOGICS EVALUATION AND RESEARCH TO THE MANUFACTURER OF THE BIOLOGICAL PRODUCT IDENTIFIED IN THE FDA LINE. THE BIOLOGICS LICENSE NUMBER IS THE U.S. LICENSE NUMBER (NOT THE STN NUMBER).
THESE CODES ARE AVAILABLE FOR USE IMMEDIATELY.
FDA WILL BE END-DATING TWO AOFC CODES THIRTY DAYS FROM ISSUANCE OF THIS NOTIFICATION. THE CODES TO BE END-DATED ARE:
BPL BIOLOGIC PRODUCT LICENSE NUMBER
BFL BIOLOGIC ESTABLISHMENT LICENSE NUMBER
CSMS #11-000258