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B&H has extensive experience in filing
submissions and representing our clients to 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: 51
§
IND Annual Reports (ARs): 53
§
IND Safety Reports: 25
§
NDAs, Amendments and Supplements: 26
§
NDA ARs: 37
§
NDA Safety Reports: 227
§
ANDAs, Amendments and Supplements: 8
§
Meeting Participation and Correspondence (regulatory strategy, requests, briefing
packages, meeting rehearsals, meeting minutes, etc.): 30
§
Orphan Drug Requests, Amendments and ARs: 8
§
DMFs/VMFs and ARs: 14
§
BLA Annual Reports: 2
§
eDRLS: 7
§
EMA Response: 1
TOTAL:
489 (32
Electronic Submissions)
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