Fda Quotations | Page 2
Fda Quotes from:
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Access Quotes
The rule we will be publishing today represents the first major overhaul of the format and content or prescribing information in 25 years. With this step, the FDA believes we are driving into the information age, out of the 20th century and into the 21st century. These changes will not only enable better access to paper information but will enable the revolution in electronic prescribing information.
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Believe Quotes
Product quality and performance have always been a top priority at Boston Scientific. We are bringing the same urgency to our overall quality and reporting management. We believe we have made a lot of progress, but we still have a ways to go. We are looking forward to our meeting with the FDA and to resolving these issues.
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Although Quotes
Although we are pleased with the result of the inspection of our largest plant, we have clearly not done enough to resolve the issues raised by the FDA last year. We are confident we have addressed many of these issues, but others have not yet been fully resolved. We will work closely with the FDA to resolve these outstanding issues, and we believe we are on track to do so promptly.
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Approval Quotes
I treated this as a public health emergency, ... A drug that had an 8-to-1 vote in favor of approval and that could any day be approved by the FDA to be used by any of 18 million Americans with type 2 diabetes was, by my analysis, doubling of risk of serious irrevocable cardiovascular events like death, heart attacks and stroke. I dropped everything.
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Actual Quotes
It's premature to put a number on the actual supply for next year because manufacturing is continuing, and there are still some uncertainties with respect to Chiron, but we are very encouraged by being able to license this new vaccine, and also I think Chiron has reached a significant milestone in terms of their recent FDA inspection. We're encouraged by the positive track they're on, although the assessment is ongoing. The bottom line is it's encouraging. We certainly are hopeful that there will be additional vaccine beyond what was available last year.
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Against Quotes
Once again, the FDA has sided with industry and against the public, in this case by concealing simple information that would allow people to easily avoid benzene in the drinks they give their children. Once people have this information, we are convinced that food and drink manufacturers will simply reformulate their products, as many already have done, and as FDA originally intended in 1990.
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Appears Quotes
The FDA on occasion will find those drugs admissible for personal use or when it appears to be a personal use quantity. The issue at hand is it's illegal, and the recipient never is assured that the same quality is going to arrive at their door step or that the drugs from the same manufacturer will arrive.
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Aged Quotes
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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Agency Quotes
In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information, ... The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction ... and reassert that the agency's top priority is what's good for John Q. Public when it comes to reviewing drugs in the marketplace.
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People Quotes
When a drug comes out [that's broadly prescribed] there are going to start to be a lot of people on it [in a million person cohort] and you might get therefore an early signal of something unexpected that hadn't come through in the clinical trials. And I'm sure [drug companies] would love it if, in fact, FDA, recognizing that, would say, OK, maybe you don't have to do your trial with 30,000 people because we're going to find out shortly after registration because we'll have a lot of people taking the drug and we'll be able to see what happened using PMI.
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Animal Quotes
FDA, which regulates the safety of vegetables, doesn't have those kinds of rules because Congress doesn't want it to. It's not that the vegetables themselves have anything wrong with them; it's that they're contaminated with animal manure. One of the rationales for a single food safety agency is that you can't separate animals from vegetables.
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Country Quotes
To speak only of food inspections: the United States currently imports 80% of its seafood, 32% of its fruits and nuts, 13% of its vegetables, and 10% of its meats. In 2007, these foods arrived in 25,000 shipments a day from about 100 countries. The FDA was able to inspect about 1% of these shipments, down from 8% in 1992. In contrast, the USDA is able to inspect 16% of the foods under its purview. By one assessment, the FDA has become so short-staffed that it would take the agency 1,900 years to inspect every foreign plant that exports food to the United States.
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World Quotes
...Only the big food manufacturers have the wherewithal to secure FDA-approved health claims for their products and then trumpet them to the world. Generally, it is the products of modern food science that make the boldest health claims, and these are often founded on incomplete and often bad science.
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Ability Quotes
The underlying problems is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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Ability Quotes
The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug - an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
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Actions Quotes
The letter that we issued to them this week is a positive development and shows significant progress on their part. However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S.
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Cancer Quotes
The field of U.S. cancer care is organized around a medical monopoly that ensures a continuous flow of money to the pharmaceutical companies, medical technology firms, research institutes, and government agencies such as the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) and quasi-public organizations such as the American Cancer Society (ACS).
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Two Quotes
Consider the clinicaltrials by which drugs are tested in human subjects.5 Before a new drug can enter the market, its manufacturer must sponsor clinicaltrials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill. The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive—that is, they show effectiveness without serious risk—the drug is usually approved, even if all the other trials are negative.
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Past Quotes
Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself.
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Caring Quotes
When birth control pills were available in Europe but not in the United States, American women created an uproar about how the unwillingness to make the pill available showed a contempt for the lives of women... When the Food and Drug Administration (FDA) released birth control pills with high dosages of hormones that were later found to be unnecessarily high, they were attacked for not caring about women enough to do the necessary tests.
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Sleep Quotes
Remember, FDA employees are serious about fear. We pay these people to panic about an iota of rodent hair in our chili, even when the recipe calls for it. FDA employees are first-class agonizers, world champions at losing sleep. When Meryl Streep got hysterical about Alar, they actually checked the apples instead of Meryl's head.
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Doctors Quotes
We need to get the government out of the way. Inflation hits the middle class and the poor the most. Those are the people who are losing it. We don't have enough competition. There's a doctor monopoly out there. We need alternative health care freely available to the people. They ought to be able to make their own choices and not controlled by the FDA preventing them to use some of the medications.