1. Pink Sheet

FDA Flexible With Accelerated Approval Evidence, Analysis Finds

 
• By Derrick Gingery

Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.

An analysis of some drugs that used the accelerated approval pathway found FDA is flexible in determining the scientific evidence needed, but also determined a strong showing among some regulatory factors likely is required.

Attorneys Frank Sasinowski and Alexander Varond, both of Hyman, Phelps and McNamara, submitted an

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