Quotes about fda
consistent current data dose fda guidance guidelines heart lowest possible shortest
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.
applaud check claims concerning considered consumers content continue corn defined defining fda grain list oats source three
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.
advanced anticipate approval attention believe candidates compound continue deficit develop disorder fda filing future half lead looking performance pipeline plan pleased positions products progress quarter receiving research second together treatment year
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.
approval believe caused child children fda happy option primary severe short stature suffer suffering treatment
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.
approved consumers contain dangers diet difficult experience fda origin people physicians pills problems products purchase side trace treat unknown
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.
becoming clearly efforts fda illogical problem safe strongly support throwing top
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.
approve chooses course fda forces less patients rely supposed
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. Alex Tabarrok
approval caused children fda happy option primary severe short stature suffering treatment
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.
devices fda improve medical net protect provide public safety strong
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. Daniel Schultz
fda goose
Wow, I got goose bumps. It's really appropriate the FDA acted. Thomas Moore
successful fda next
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.
fda meant
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. Leroy Hood
fda years creating
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. David Mixner
fda managers
My manager says we've been working with the FDA on this. Carlos Gonzalez
additional benefits choice clearly decisions fda finding foods found health people priority top ways
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.
best countries engage fda firm framework health indian issue market ministry process repeated share trials
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, Kapil Sibal
banned begins certain fda found further high injuries marketing serious short time within
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.
abortion agency approval approving believe bent brought clearly fda fear followed health industry law proposed rules supporters valued
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.
clearly defined fda guidance waiting
We've been waiting for more guidance. Today, the FDA has clearly defined what is and what is not a whole grain.
advice avoid benefits fda help king limit people per post six stores tuna warning
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.
act address approve fda hour late legal months needed option question quickly resolved until urge waited
I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago. I urge FDA to act quickly to approve this needed reproductive option for women. Edward Kennedy
address bring closely committing company continue deliver fda innovative medicines necessary order patients promise quickly resources work
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.
advice fda medical prepare products safely specific
Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.
applaud bipartisan chairman commerce committee congress dedication edward energy fda include joe john leadership member moving original passage senators sponsor sponsors
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.
across bush coming fda fund ignored labeling meat products provisions refuses resources
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. Dick Gephardt
choices consumers fda grocery informed
I find that the FDA has been really paving the way for consumers to make more informed choices at the grocery store.
advisory fda pet
That FDA advisory is one of my all-time pet peeves.
approved fda good marketing quite sure tool
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.
advisory asleep committee fda question stand willing
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?
approved becomes concern fda generic prices valid whether
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, Richard Watson
continues fda monitor
I think it's very important the FDA continues to monitor this. Nancy Greene
ahead almost difficult fda gotten problem
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.
fda follow full
I think that the FDA will follow up with full approval,