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Antiepileptic drug for 2 distinct indications

Antiepileptic drug for 2 distinct indications
Combined meeting of the Peripheral and Central Nervous System Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee, with representation from the Risk Communication Advisory Committee.
Primary Challenges:
- Two distinct indications and populations, each with its own unique benefit/risk profile presented over 2 consecutive days
- A potential clinically meaningful visual defect that is difficult to detect
- Committee meeting postponed due to FDA difficulties in empanelling experts

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Antiviral drug for an indication with broad public health implications

Antiviral drug for an indication with broad public health implications
Antiviral Drugs Advisory Committee

Primary Challenges
- First NDA for the organization. Very few individuals had previously been involved in an NDA or participated in an advisory committee meeting.
- Large amounts of complex virology and clinical data from bench to multiple large phase 3 trials
- Dosing strategy not typical in the field with concomitant administration of standard of care

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Antimetabolite for an orphan oncology indication

Antimetabolite for an orphan oncology indication
Oncology Drugs Advisory Committee

Primary Challenges:
- No standard of care
- Patient population consisted of a heterogeneous mixture of histologic subgroups that did not all appear to benefit
- Small, single-arm trial with primary end point of objective response rate
- Assessment of response duration confounded by extensive censoring

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