|
B&H has extensive experience in filing
submissions and representing our clients to FDA. We have
coordinated and participated in more than 175 formal face to face
meetings, as well as informal teleconferences with FDA. We interact
with FDA on a daily basis. An overview of B&H's activities are
highlighted below. Please contact us to learn more about how we
can provide regulatory support to your organization.
Total FDA Submissions/Meetings
§
INDs and Amendments: 98
§
IND Annual Reports/DSURs: 130
§
IND Safety Reports: 10
§
NDAs/BLA Amendments and Supplements: 43
§
NDA/BLA ARs: 65
§
NDA/BLA Safety Reports: 238
§
ANDAs, Amendments and Supplements: 16
§
Meeting Participation and Correspondence (regulatory strategy, requests, briefing
packages, meeting rehearsals, meeting minutes, etc.): 53
§
Orphan Drug Requests, Amendments and ARs: 11
§
Master Files, Amendments and ARs: 15
§
eDRLS: 33
§
Inspection Correspondence: 3
2011 TOTAL:
714 (121 Electronic Submissions)
|
