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

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