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.
Quotes about fdas (16 Quotes)
The results clearly demonstrate the need for signs in our supermarkets to communicate the FDA advice because people are unknowingly purchasing these high-mercury fish, and women of childbearing age and children may be eating them in spite of the FDA's warning.
Some of the FDA's own scientists have charged that politics, not science, is behind the FDA's actions.
Hundreds of thousands of women would get unsafe exposures to mercury if they followed the FDA's advice and ate freely of all fish in the food supply except the four that they've prohibited during pregnancy,
It's disappointing to us that the case played out this way. While we disagreed with the FDA's methodologies and conclusions, consumers should be comforted by the fact that the agency does have sufficient authority to act when it thinks there's a threat to public health.
With this action, the president in essence has accepted the FDA's determination that cigarettes and smokeless tobacco are delivery devices for the drug nicotine,
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 will not tolerate the FDA's decision to approve the destruction of innocent human persons through chemical abortion.
If the judgment is that there's blood on Merck's (nyse MRK - news - people ) hands, ... there's blood on the FDA's hands as well.
We finally have the FDA's support, the ability to provide needed drugs to those that are suffering from cancer,
FDA's recommendation to adopt RFID technology by 2007 has been an everyday conversation with brand owners. In some cases, the term RFID has become the umbrella name to loosely describe initiatives to meet local government requirements in electronic pedigree, track and trace, and brand authentication, all of which may work in tandem with RFID, but equally can be implemented and referred to as a stand-alone application or solution.
FDA's action today is another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe manner,
In effect, it's an empty promise, ... The FDA's drug advertising division has been drastically understaffed for decades, and there's no reason to believe that will change anytime soon.
We believe that the FDA's immediate concern level with the products is low and see black box as unlikely. A medication guide is more likely because of the strong panel vote in its favor.
The FDA's action level is four times less stringent than the EPA's warning,
It's a major public health failing on (the FDA's) part, ... and we feel quite strongly that they need to aggressively look into the problem of mercury contamination of fish, expand the list of fish that women need to avoid and get this information out to the medical community and to women in a much more aggressive way.