Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation
US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.
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The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.
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.