Search Results for BsUFA II

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HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees By Zachary Brennan - Published 17 May 2017

Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Tom Price, MDUFA IV, BsUFA II, PDUFA VI, GDUFA, user fees

FDA Officials Share Best Practices for Biosimilar Development By Michael Mezher - Published 28 October 2016

With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars, BsUFA II

Biosimilar User Fees: FDA and Industry Reach Agreement By Michael Mezher - Published 27 June 2016

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory strategy, Submission and registration

Tags: BsUFA, BsUFA II, Biosimilar User Fee Act