1. Pink Sheet

Therapeutic Equivalence Evaluations Would Be Required For 505(b)(2) Drugs Under Senate User Fee Bill

 
• By Brenda Sandburg

The Senate HELP Committee added a therapeutic equivalence provision to the draft measure it floated two weeks ago. The bill introduced in the Senate still does not include provisions on clinical trial diversity or 180-day exclusivity.

Equivalence
FDA would have to provide therapeutic equivalence codes for certain generics under Senate user fee bill • Source: Shutterstock

The Senate user fee reauthorization bill would enable sponsors to get a therapeutic equivalence rating for products approved under the 505(b)(2) pathway rather than go through the onerous process of filing a citizen petition.

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