16/01/2024 Other Services
In 2023, FDA's Center for Drug Research and Evaluation (CDER) approved 55 novel drugs. The active ingredient(s) in a novel drug have not been previously FDA-approved.
In addition, the agency approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter (OTC).
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
https://www.itbhdg.com/drugs/
In 2023, FDA's Center for Drug Research and Evaluation (CDER) approved 55 novel drugs. The active ingredient(s) in a novel drug have not been previous...
FDA Prescription Drug User Fees for fiscal year 2023 Application Requiring clinical data: $3,242,026 Not requiring clinical data: $1,621,013 Program $...
FDA Prescription Drug User Fees for fiscal year 2023 Application Requiring clinical data: $3,242,026 Not requiring clinical data: $1,621,013 Program $...
For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544),...
More Details