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California Life Sciences Association (CLSA), the statewide public policy and business leadership trade association representing California’s innovative life sciences industry, today applauded the strong, bipartisan U.S. Senate passage of H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, to renew the FDA’s authority to collect user fees, and make critical improvements for the agency’s medical device and prescription drug review programs. The CLSA-supported legislation, already approved by the U.S. House, passed the U.S. Senate today by a vote of 94-1, and now goes to President Trump for signature. This statement can be attributed to Sara Radcliffe, President & CEO of CLSA:
“California Life Sciences Association (CLSA) applauds the strong, bipartisan Congressional approval of the FDA Reauthorization Act (FDARA) of 2017. This important legislative package renews the FDA’s user fee programs for medical devices and prescription drugs, ensuring the agency has access to critical funding to support its regulatory responsibilities for the coming years.
“With more than 3,000 life sciences companies throughout California working to develop solutions to some of the world’s most challenging diseases, a well‐funded, science-based FDA and consistent, predictable and transparent product review processes are critical for encouraging continued biomedical investment, innovation and improvements in patient care. In addition to renewing the agency’s authority to collect user fees, H.R. 2340 enhances FDA’s regulatory functions. CLSA also applauds the inclusion in the bill of several measures of importance to the life sciences sector, including a provision from San Diego Congressman Scott Peters to improve and streamline medical device facility inspections.
“The FDA Reauthorization Act of 2017 is critical to providing certainty to the FDA’s operations so that patients can obtain new therapies and technologies in a timely and efficient manner. On behalf of the hundreds of life sciences organizations up and down the state we embody, California Life Sciences Association urges the Administration to swiftly sign FDARA into law so that California and the U.S. remains the worldwide leader in life sciences research, investment and innovation.“
The FDA Reauthorization Act (FDARA) of 2017 was approved by the U.S. House of Representatives by a voice vote on July 12, 2017.
About HR 2430, The FDA Reauthorization Act (FDARA) of 2017:
H.R. 2430 would reauthorize the Food and Drug Administration (FDA) user fee programs for medical devices, prescription drugs, biosimilars and generic drugs. User fees are collected from companies that develop drugs and medical devices, and substantially contribute financial resources for FDA’s premarket review activities. H.R. 2430 also includes several provisions to improve FDA’s drug review process, including greater use of real-world evidence and enhancing drug development tools such as biomarker development. FDA’s review activities are critical to promoting rapid access to innovative therapies and driving competition toward better healthcare results and lower prices for American consumers. Improvements in FDA’s premarket review process, funded by these user fee programs, have encouraged drug and device makers to expand research and development, leading to advances in medical technology that have saved and improved countless lives. Learn more.
About California Life Sciences Association (CLSA)
California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at www.califesciences.org, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.
California Life Sciences Association (CLSA)
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