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Are Any 340B Sub-Regulatory Guidelines and Policies Binding?

16 September 2014

Drug Discount Monitor

The fallout from last May’s 340B orphan drug exclusion court decision casts doubt over whether certain 340B program requirements are binding, a prominent attorney for manufacturers said at an industry conference in Chicago today.

Read more: Are Any 340B Sub-Regulatory Guidelines and Policies Binding?

The team

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