Fda Quotations

I like food. I like eating. And I don't want to deprive myself of good food.

You can't treat an illness with cosmetic surgery, and that's why it would be great if there were qualified therapists in plastic surgeons' offices, and that people would go to a therapeutic meeting before plastic surgery. I think that should be part of the FDA requirement.

If a State has reliable scientific information that demonstrates that a warning is needed for a particular food, then in the interest of public health, it should share that information with the FDA and petition for a new national standard.

Education exposes young people to a broader world, a world full of opportunity and hope.

The simple truth is, the short-term solution is for the FDA to allow more importation of safe vaccines from other nations. But the long-term solution is to get more vaccine production within the U.S.

The FDA is redefining birth control as abortion. The FDA is setting the bar higher for this kind of drug.

When the FDA forces an old drug off the market, patients have very little say in the matter. Patients have even less of a say when the FDA chooses not to approve a new drug. Instead, we are supposed to rely on the FDA's judgment and be grateful. But can the FDA really make a choice that is appropriate for everyone? Of course not.

When people lack jobs, opportunity, and ownership of property they have little or no stake in their communities.

For me, first, it's finding quiet in my life - and I do that through yoga and meditation. It's also been a matter of changing the way I eat, because I think what we eat can inform who we are; food is a chemical and a drug to a certain extent.

FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care.

If you go to the FDA with a drug that's only meant to treat 50 people, and it's a 95 percent cure rate, you'll get your drug approved.

The public properly relies upon FDA classification of drugs as nonprescription as a reflection of the agency's judgment regarding the safety and proper use of a drug without a doctor's prescription.

Nothing is more expensive than a missed opportunity.

We applaud the FDA for defining what whole grain is. Unfortunately, the FDA has not defined any claims concerning the grain content of foods. Consumers should continue to check labels. Grains such as wheat, rice, oats or corn must be described as 'whole' in the list of ingredients to be considered a significant source of whole grain and also should be one of the first three ingredients listed.

We are pleased with our performance in 2005. The year was highlighted by the filing of the new drug application on NRP104, our lead compound under development, for the treatment of Attention Deficit Hyperactivity Disorder in pediatric populations. We believe that this advancement together with the progress on our other pipeline products positions us well for future growth. Looking forward, we anticipate receiving approval from the FDA on NRP104 in the second half of 2006 and making IND filings on NRP409 and NRP388, the two most advanced candidates in our preclinical pipeline, by the end of the second quarter of 2006. In addition, we plan to continue to develop NRP290, our second most advanced compound, and other drug products in our research pipeline.

We believe that no child should suffer from a preventable or treatable disorder. With today's FDA approval, we are happy to know that there is a new treatment option for children suffering from short stature caused by severe Primary IGFD.

There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality. These products are not approved by the FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them.

We strongly support efforts to make shellfish safe for consumers, but irradiation clearly is not the answer. The FDA is just throwing one problem on top of another - and this is becoming an illogical pattern.

We feel that our data are completely consistent with the current American Heart Association guidelines and the current FDA guidance to use the lowest possible dose for the shortest possible duration.

Over the years, HIV/AIDS activists and their allies have been pioneers in creating new frontiers in the medical establishment. Through their efforts, the FDA drug approval procedures were reformed so promising new therapies could reach desperate patients quicker.

With today's FDA approval, we are happy to know that there is a new treatment option for children suffering from short stature caused by severe Primary IGFD.

With this initiative, FDA intends to improve the way it monitors the safety of medical devices and provide a strong safety net to protect public health.

Wow, I got goose bumps. It's really appropriate the FDA acted.

My manager says we've been working with the FDA on this.

It's unfortunate, and we're disappointed the FDA did not grant the stay, ... But because there are no new scientific findings other than what the poultry groups submitted already, the likelihood of the company being successful in a further legal action is next to nil.

The FDA has received over a million comments from citizens demanding labeling of GMOs. 90 percent of Americans agree. So, why no labeling?

We hope to learn more about the status of the FDA letter on Tuesday.

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.

Since 1994, any herbal remedy sold as a dietary supplement -- no matter what their real purpose -- the FDA has no authority over them,

Most studies submitted to the FDA have been conducted by the manufacturers of implants who obviously have a vested interested and whose findings are frequently biased and misleading. We must reform this heavy reliance on industry, which interferes with sound scientific decision-making by the FDA.

Most people are looking at the vote, not at what the FDA said. Six of the 10 panelists said the safety data is not sufficient, but with more data, they think the vaccine will pass. The FDA wants to see this pass.

My guess is the government has spent at least that much themselves, ... and there have been literally hundreds of FDA people involved in this over a four-year period of time.

Phase 2 studies are typically well controlled and closely monitored and may involve up to several hundred patients. At the conclusion of these studies, FDA (Food and Drug Administration) and the sponsor usually meet to determine how the drug's development should be studied in Phase 3 and how to design and conduct further trials.

One of the most important decisions people can make about their health is the choice of foods they eat. A top priority at FDA is finding additional ways to clearly communicate the health benefits found in food.

If we get such a world-class certifying process in India, the issue of going in for repeated trials in each of the countries by a firm to market its drugs will be eliminated. The Indian Health Ministry is working out the framework and we will engage FDA to share their best practices,

If we could just get the stores to post the FDA advice, warning people to avoid swordfish, shark, tilefish and king mackerel, and to limit albacore tuna and tuna steaks to six ounces per week, that would go a long way to help people get the benefits without the risks.

I am committing all the necessary resources of the company to address these issues, ... We will continue to work closely with the FDA in order to deliver on our promise to bring these innovative new medicines to patients as quickly as possible.

I applaud Congress for the passage of FALCPA. Chairman Joe Barton and Ranking Member John D. Dingell in the House, Energy and Commerce Committee were instrumental in moving this bipartisan legislation forward. Representative Nita Lowey was the original sponsor of the legislation. FDA also applauds the dedication and leadership of the legislation's sponsors in the Senate, which include Senators Judd Gregg and Edward Kennedy.

Bush refuses to fund important country-of-origin labeling provisions for meat and has ignored the need for resources at the FDA and USDA to inspect the agricultural products coming across our borders.

I find that the FDA has been really paving the way for consumers to make more informed choices at the grocery store.

If a conventional pharmaceutical company had this kind of quality control, the FDA would shut them down in a heartbeat.

I expect that whoever is named commissioner, either acting or confirmed, will know that it's not possible to give the FDA the kind of strong new leadership that is needed to reinvigorate the agency on a part-time basis.

I don't think people want the FDA to say what should be done about teen pregnancy or other social issues,

If the FDA approves this drug, it is certain that it will have to be banned within a short time after marketing begins because of the high probability of further occurrence of the serious injuries it has already been found to cause.

If supporters of RU-486 believe the FDA followed the law in approving RU-486 for abortion, they should have nothing to fear from the proposed review. But if the FDA bent the rules to expedite approval of RU-486, the agency clearly valued the 'health' of the abortion industry over women's health and should be brought to account.

We've been waiting for more guidance. Today, the FDA has clearly defined what is and what is not a whole grain.

Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.

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.

It is a good marketing tool that the FDA has approved it, so I am quite sure they will make some inroads in the U.S. That is for sure.

I think the FDA advisory committee was asleep at the switch, ... The question is, did they not get it, or did they get it and were not willing to stand their ground?

I think what is a valid concern is an overburdened FDA, and whether the FDA becomes more of a bottleneck to getting new generic drugs approved and getting the prices of drugs down,

I think it's very important the FDA continues to monitor this.

I think it's probably almost 50-50 the FDA says, 'go ahead and give us the documentation for filing,' ... The problem is that historically the FDA's always gotten more difficult in these cases.

I think that the FDA will follow up with full approval,

It is not FDA approved to skip periods on the ring, ... but this study and other studies using the oral contraceptive are finding that for many women this might be an option.

I think that what we continue to learn is that the hurdle rate of the FDA has gotten higher,

It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer.

It is an extremely dangerous drug, and it's just reckless for any company to be selling it, and it's reckless in the extreme for the FDA to allow this to stay on the market.

Our initial conclusion was that, to date, those materials do not alter the conclusions reached by FDA about Prozac.

Over the years, HIV/AIDS activists and their allies have been pioneers in creating new frontiers in the medical establishment. Through their efforts, the FDA drug approval procedures were reformed so promising new therapies could reach desperate patients quicker.

Regardless of how you feel about whether Plan B should be available in the community, the fact is the FDA decision should be based on science, not cultural controversy,

Recent FDA actions have created serious doubts about whether committee members are serving only the public interest and, as a result, industry biases now taint many advisory panel decisions, ... Today we took a giant step forward to squash those doubts.

Our position is that DTC ads are just an extension of the general drug safety problems and the FDA needs broader authority on drug safety generally.

That FDA advisory is one of my all-time pet peeves.

My colleagues and I were quite surprised that the FDA has taken such an extreme position,

While the FDA seeks assurances that we will maintain and continue our quality commitment, we understand that the safety and quality of our products is not at issue.

We're delighted that the FDA has moved forward at all. The worst thing for manufacturers and consumers is limbo.

We're delighted that the FDA has moved forward at all.

We believe these are reasonable protections for women's health. This is not an effort to roll back and repeal the FDA approval. We believe safety concerns were compromised.

We had made all the data available to the FDA, the medical community and the general public in all sorts of ways. So we felt the most proper and most responsible thing to do was work that process with the FDA and the medical community.

We have clearly not done enough to resolve the issues raised by the FDA last year. 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.

We're not at maximum prevention. We would like the FDA to reconsider this matter, hold hearings and act as soon as they can.

Today, the FDA sent a clear message that all candies sold in the United States, regardless of their country of origin, must meet the same, stringent safety standards.

The problem isn't with the FDA not approving drugs fast enough; it's that the drug industry isn't coming up with enough new drugs.

Watson is committed to working with the FDA to reach resolution of the issues raised in the letter in a prompt manner. While this is disappointing, we firmly believe that we can address the FDA's issues and gain approval of this product.

We are disappointed that the FDA did not approve our application. While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product.

We are disappointed that the FDA did not approve our application,

We still have to see if the FDA will follow this recommendation, but the signs from the meeting are positive.

The FDA has formed a rapid response team.

For the first time since 2007, the FDA Has approved a new device to treat obesity. The amazing breakthrough is called a vegetable.

We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge.

We've got to do a better job of segregating those commodities to make sure that ... we basically protect people from things that haven't been approved, ... The FDA is monitoring the situation very closely, very carefully. I don't think there is any public health and safety issue here, but the fact is the product has not been approved for human consumption. It should not be served.

While I was pleased to receive assurances that the agency will, in the coming weeks, deliver a long overdue decision on Plan B, concerns about Dr. Crawford's leadership remain, ... I have been continually concerned during Dr. Crawford's tenure that FDA hasn't shown the independence and adherence to science necessary to inspire public confidence.

While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product.

We had asked for the FDA to consider two other options. One is to get rid of these colorings completely and let companies replace them with safer ingredients. But if the FDA decided to require labeling, at least to indicate that these are insect derived.

The public deserves to know whether this is a case of FDA incompetence and a lack of diligence, or whether the FDA made a decision to protect the company's confidentiality over the public health. Either way, we have a serious problem on our hands.

What the FDA seemed to be saying is that it doesn't know if Boston Scientific has a systemic, corporate-wide quality policy, and until it does the FDA will not permit the company to gain product approvals in adulterated plants.

This non-decision is further evidence that the FDA has allowed politics to trump science - especially now that the process is 'rule-making,' which always ultimately stops at the White House,

We want consumers to be aware that when they order online from these sites ... for the most part no one is overseeing that -- not the state boards of pharmacy, not the FDA -- and that they're the ones responsible for taking a look at the quality of these sites and their offerings.

Benzene is a potent carcinogen that has no place in foods and drinks targeted to children. We urge the FDA to immediately issue a statement telling consumers which ingredients in foods and drinks can combine to form benzene.

Diamond Pet Foods has cooperated fully with the FDA during its investigation.

Don't let them come in here and fool us, ... when they have this attitude about the FDA and then hide behind the FDA.

Are you saying that if heroin were legalized, the FDA could not regulate it?

FDA will be immediately notified and will take appropriate regulatory action if any serious safety concerns are identified,

FDA scientists and employees are by and large hardworking and committed to fulfilling the agency's mission. They deserve a commissioner who will reinvigorate the agency.

FDA is no longer able to make the kinds of demands for scientific information and validation of safety that they used to, on people who are selling food supplements.

FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications. We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.

FDA continues to warn consumers to avoid consumption of dietary supplements containing ephedrine alkaloids. We will continue to do all we can to protect the public health against these dietary supplements that have been found to cause serious illness and injury.

FDA approval should be the gold standard for comprehensive examination of drug safety. We shouldn't be second-guessing the agency's processes.

FDA allowance to export the cartridges made at our San Diego plant was the final regulatory hurdle we needed to overcome in order to start treating patients in our pivotal clinical trial in China. Personnel are now being trained and cartridges manufactured so we can begin patient treatment early in 2006.