Record of Telephone Conversation, April 8, 2014 - RAGWITEK

Submission Type: BLA Submission ID: 125478/0 Office: OVRR
 Product:
 Short Ragweed Pollen Allergen Extract
 Applicant:
 Merck Sharp & Dohme Corp.
 Telecon Date/Time: 08-Apr-2014 01:57 PM Initiated by FDA? Yes
 Communication Categorie(s):
 1. Information Request
 Author: DEBORAH TROUT
 Telecon Summary:
 Information Request regarding ---(b)(4)--- monitoring of the drug substance.
 FDA Participants: Deborah Trout
 Non-FDA Participants: Scott Greenfeder, Ph.D.
 Telecon Body:
 Deborah Trout e-mailed Scott Greenfeder, Ph.D., to request additional information regarding ---(b)(4)--- testing of the drug substance during manufacturing. E-mail attached.

From: Trout, Deborah
Sent: Tuesday, April 08, 2014 1:57 PM
To: scott.greenfeder@merck.com
Cc: Rivers, Katie; Renshaw, Carolyn
Subject: Ragweed Question

Scott – There appears to be no ---(b)(4)--- monitoring of the drug substance during manufacturing, except at release. Please provide historical data demonstrating---(b)(4)--- control during any open processing step, or your corrective action plan to address the lack of monitoring. Thanks - Deb
