Search Results: U.S. FDA News

UPDATED: FDA Requesting Comments on Biomarker List

FDA has announced the opening of a docket (FDA-2016-N-2610) for interested parties (academic researchers, regulated industries, consortia, patient groups, etc.) to submit suggestions, recommendations and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and new biological therapeutics from October 2007 to December…

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FDA Announces Biosimilar User Fee Rates for FY 2017

The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year: FY17 BsUFA Fees Biological Product Development Initial $203,810 Annual $203,810 Application w/Clinical Data $2,038,100 w/o Clinical Data $1,019,050 Supplement w/Clinical Data $1,019,050 Product $97,750 Establishment $512,200 Reactivation $407,620 The biosimilar user fees for a given fiscal year…

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FDA Offers Perspectives on Enhancements to the Application Review Model

In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle…

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