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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
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INDs and Amendments: 92
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IND Annual Reports (ARs): 92
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IND Safety Reports: 31
§
NDAs, Amendments and Supplements: 36
§
NDA ARs: 55
§
NDA Safety Reports: 322
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ANDAs, Amendments and Supplements: 20
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Meeting Participation and Correspondence (regulatory strategy, requests, briefing
packages, meeting rehearsals, meeting minutes, etc.): 34
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Orphan Drug Requests, Amendments and ARs: 6
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Master Files, Amendments and ARs: 17
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BLA Annual Reports: 3
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eDRLS: 25
2010 TOTAL:
733
(72 Electronic Submissions)
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