BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA
Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”
In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the Food and Drug Administration’s (FDA) implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.
“A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products,” Radcliffe testified.
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