Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill
Executive Summary
Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.
You may also be interested in...
Therapeutic Equivalence Evaluations Would Be Required For 505(b)(2) Drugs Under Senate User Fee Bill
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.
Therapeutic Equivalence Evaluations Would Be Required For 505(b)(2) Drugs Under Senate User Fee Bill
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.
US FDA Accelerated Approval Council Required Under Senate User Fee Bill
Intra-agency group would be tasked with ensuring consistent use of the expedited pathway across the FDA, with duties potentially including development of best practices, product review team training, and advising on withdrawals, according to the Senate's bipartisan user fee legislation.