
Record of Telephone Conversation(2), August 2, 2011 - Anascorp
 
 
 

Submission Type: BLA    Submission ID: 125335/0    Office: OBRR

Product:

Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection

Applicant:

Rare Disease Therapeutics, Inc. (RDT)

Telecon Date/Time: 02-Aug-2011 11:30 AM        Initiated by FDA? Yes

Telephone Number: (619) 328-5370 (for teleconferencing, the Firm called into the office of D. Ertel at 301-827-7121)

Communication Categorie(s):

1. Other - Post Marketing Commitments

 

Author: DONALD ERTEL

Telecon Summary:

Discussion of Post Marketing Commitments

FDA Participants: Donald Ertel, Deborah Trout

Non-FDA Participants: RDT: Jennifer Spinella, ------(b)(4)------

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:



We requested the following PMCs:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------.
--------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------.

We also requested the following written commitments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

 

Call ended at 11:40am

 