Tag Archives: FDA

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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BIO Investor Forum – Raring to Go: The Race to Treat Ultra-Rare Diseases

BIO Investor Forum

The signing of FDASIA by President Obama in July reinforces the country’s commitment to fostering innovation for rare diseases. With a record 460 medicines in late-stage clinical trials, biopharmaceutical companies have embraced rare disease medicine and are rapidly developing the pipeline. In anticipation of an even more compelling opportunity, many companies are taking a step beyond and focusing on ultra rare diseases. Last week’s 11th Annual BIO Investor Forum in San Francisco hosted a panel, Raring Read More >

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“Approval of Foods from Genetically Modified Animals is Unjustifiably Slow”

salmon

The Los Angeles Times reported on concerns within the U.S. animal biotech industry and the chilling effect that will result if the government continues to turn its back on technologies in the pipeline. If the political process doesn’t allow the science-based regulatory process to work, we risk losing out on the benefits of this dynamic industry to other countries that are encouraging research and investment in this area. Rosie Mestel of the Los Angeles Times 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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