Tag Archives: PDUFA

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

FDA115x76

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 Originally enacted in 1992, it must be reauthorized every 5 years.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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Empowering You to Make a Difference in Health Care Policy

CMM

Access to medicines. Healthcare reform. Innovation. These issues are critical to the health of Americans — and the Campaign for Modern Medicines is working on them every day. The Campaign for Modern Medicines is a coalition of non-profit organizations, businesses, and individuals from across the country who believe that a vibrant community of empowered advocates can make a real impact on the policy decisions that will improve our health. With the support of our partners, Read More >

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FDA Safety and Innovation Act: A Step Forward for Patients With Rare Diseases

Peter L. Saltonstall

By Peter L. Saltonstall, President and CEO, National Organization for Rare Disorders (NORD) The Food and Drug Administration Safety and Innovation Act (FDASIA) includes the most groundbreaking measures for rare disease patients and their families since the Orphan Drug Act of 1983.  And, just as the rare disease patient community—with NORD as its unifying voice—played a major role in the Orphan Drug Act, NORD and rare disease patients have taken a leadership role in developing Read More >

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