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Novel drugs (2015): A report on the more innovative products approved by FDA. These products often help advance clinical care to another level. Each year, FDA approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already-approved products, or cost-saving generic formulations. These new products contribute to quality of care, greater access to medication, more consumer choice, and a competitive marketplace that enhances affordability and public health.
FDA is committed to ensuring user fee resources are administered, allocated, and reported in an efficient and transparent manner. Under PDUFA VI, BsUFA II, and GDUFA II, FDA committed to evaluating the financial administration of these user fee programs to help identify areas to enhance efficiency.


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