Tag Archives: PDUFA

#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

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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

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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

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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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FDASIA: A Step Forward for Patients

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Earlier this year, Congress passed and President Obama signed the FDA Safety and Innovation Act (FDASIA) which included a re-authorization of the Prescription Drug User Fee Act (PDUFA). PDUFA provides essential funding to the FDA by authorizing the agency to charge user fees to companies seeking to have products reviewed. Originally enacted in 1992, it must be reauthorized every 5 years. Sara Radcliffe, executive vice president of health at BIO, moderated a panel of experts and advocates Read More >

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