14 ordspråk av Lester Crawford
Lester Crawford
[How to enforce an age limit is the] key unresolved question, ... FDA cannot have an inspector in every pharmacy.
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[The issue has raised] many difficult and novel policy and regulatory issues, ... We need to resolve these policy and regulatory questions before we can reach a decision on the underlying science.
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Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines, ... I commend our Center for Biologics for taking extraordinary steps to help us be better prepared for both the upcoming and future flu seasons.
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I also must thank the extraordinary people of FDA for the honor of having served with them, ... They have made public service a joy and a pleasure as we worked together to accomplish great things for public health.
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I think we're going to come close to Canada at the end of the day,
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Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market,
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Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market, ... Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines.
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talented and smart, and I am delighted to have been able to recruit him back to the agency to help me fulfill our public-health goals.
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The FDA also encourages consumers to learn about potential savings through Medicare's outpatient prescription drug coverage, ... This new program comes at a time when five out of six people aged 65 and older are taking at least one medication, and almost half of all elderly people take three or more.
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There are unique regulatory issues that need to be addressed, ... We can only decide these issues in an open process. That will let us decide whether FDA can approve a drug for both over-the-counter and prescription use, for the same indication, sold in the same package.
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These are profound regulatory decisions,
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We believe that there may be means to develop this kind of vaccine without use of egg-based product, ... We believe there needs to be some research into that.
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We're aware that there are many social and ethical issues related to the cloning of animals.
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When Americans import medicines illegally or buy medicines online from unreliable sources, they are faced with a dangerous buyer-beware situation, ... The FDA understands why people who are having a hard time paying for prescription drugs might do this. We have been expanding our generic drug program to help make more affordable prescription drugs available. This is one solution that does not put consumers at risk.
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