Tag Archives: PDUFA

Setting the Stage for PDUFA VI: Recap of Stakeholder Briefing

On July 15, 2016, the U.S. Food and Drug Administration (FDA) released the Prescription Drug User Fee Act (PDUFA VI) Goals Letter for fiscal years 2018 through 2022.  The Goals Letter, thoughtfully negotiated by the FDA and biopharmaceutical industry with input from the patient and provider stakeholder communities, outlines the performance goals committed to by the FDA and the biopharmaceutical industry to evaluate drug safety, improve the speed and efficiency of the FDA’s drug review Read More >

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#BIOCEO16 Session Recap: Regulatory Policy Outlook—PDUFA VI and You

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The second day of #BIOCEO16 kicked off this morning with a look ahead to PDUFA VI and potential ways to improve the drug development and approval process. Moderated by BIO Executive Vice President of Emerging Companies Cartier Esham, the panelists included: Elizabeth Krutoholow, Analyst, Bloomberg Intelligence Jonathan Leff, Partner, Deerfield Management; Chairman, Deerfield Institute Richard F. Pops, Chairman & Chief Executive Officer, Alkermes The challenges and opportunities presented by the growing amount of available “real Read More >

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Biotech Policy Outlook at #BIF15: 21st Century Cures, IPR, TPP, and PDUFA VI

To even the most casual observer, 2015 has been a big year in the biotech industry, particularly in Congress and in other venues wherein public policies that affect the sector take shape. Given the importance of the policy environment in determining how successful companies in our industry can be at delivering new cures and treatments to patients – and a return to the investors who finance their activities – we decided that a close look Read More >

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Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems


In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee Act (PDUFA). This program ensures that FDA has the ability to hire additional reviewers to expedite the drug review process by having industry pay “user fees.” Recently, attention has been given to a flawed study in the August 2014 issue of Health Affairs, which has some critics claiming that PDUFA fees are biasing FDA review decisions. The study looked at Read More >

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U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14


During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, co- chair of the Congressional Biomedical Research Caucus, joined BIO’s Fritz Bittenbender to discuss the biotech industry in Pennsylvania as well as recent legislative developments affecting the industry. Dent points to the recent omnibus spending agreement which allowed the Food and Drug Administration (FDA) to access user $85 million in user fees sequestered in 2013. These fees are paid to Read More >

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