Record of Telephone Conversation, March 7, 2014 - RAGWITEK

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA
Submission ID: 125478/0
Office: OVRR
Product:
Short Ragweed Pollen Allergen Extract
Applicant:
Merck Sharp & Dohme Corp.
Telecon Date/Time: 07-Mar-2014 10:45 AM
Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):

1. Advice

Author: JENNIFER BRIDGEWATER
Telecon Summary:
Request to submit the response to 483 observations made during the PAI to the BLA.
FDA Participants: Jennifer Bridgewater
Non-FDA Participants: Scott Greenfeder, Ph.D.
Telecon Body:

Ms. Bridgewater spoke to Dr. Greenfeder regarding ALK’s response to the 483 observations received during the recent PAI inspection for BLA125473 and BLA125478. Dr. Greenfeder stated that response to the 483s had already been submitted to the investigator. Ms. Bridgewater clarified that per Deborah Trout’s request and standard procedures; he needed to submit the 483 responses to both BLAs. Dr. Greenfeder asked if they should submit the biennial inspection response. Ms. Bridgewater confirmed that this was not necessary and only the responses/documentation related to the PAI part of the inspection should be submitted. Dr. Greenfeder confirmed that the responses to 483 observations would be submitted as an amendment to each BLA as soon as possible.
