Tag Archives: FDA

Simpson Bowles Keynote to Address Debt, Taxes, Government Services and Politics

Jim Greenwood

I was recently asked what the single biggest threat to the biotechnology industry is today.  My answer was immediate – the biggest threat to biotech innovation is the unsustainable mismatch of spending and revenue in the U.S. federal budget. The enormous national debt and the huge annual budget deficits that feed it endanger America’s entire economic future – but the nation’s dire fiscal situation is particularly threatening to our industry. Part of the reason for Read More >

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California Biomedical Companies Cite Lack Of Funding As Major Concern

Investment

As I have mentioned in past blog posts, the U.S. bioscience industry has demonstrated stability through turbulent economic times. While not immune from the recession, this industry generally fared much better than the overall economy and has remained a net a job generator. In April of 2012, the White House released the National Bioeconomy Blueprint noting that bioscience industries are “a large and rapidly growing segment of the world economy that provides substantial public benefit.” Read More >

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FDASIA: A Step Forward for Patients

fdasia-panel

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 Originally enacted in 1992, it must be reauthorized every 5 years.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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Public Health at Risk: Don’t Cut Programs that Work

cliff

In order to avoid the “fiscal cliff,” the Congress must compromise and protect our economic future by cutting costs and raising revenue, without compromising our nation’s support for critical government programs. Programs vital to the health of our nation – quite literally – should not suffer dramatic cuts. Making cuts to these programs could actually cost our nation more in the long run. The unintended consequences could impact our economic health, as well as our Read More >

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“When Genetic Engineering Came Of Age”

insulin

October 29 was the 30th anniversary of the approval by the Food and Drug Administration (FDA) of human insulin synthesized in genetically engineered bacteria. In an article for Forbes, Henry Miller, the founding director of the FDA’s Office of Biotechnology, marked the anniversary and commented on today’s regulatory environment: “Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by Read More >

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