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.
Quotes about fda (16 Quotes)
I think that the FDA will follow up with full approval,
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.
The big drug companies are under duress on almost every front. There are challenges everywhere from generics, from the FDA, from managed care and from self-appointed public watchdogs criticizing the industry, and with attacks on direct-to-consumer advertising,
The assurance of a decision by Sept. 1 came in a letter from Health and Human Services Secretary Mike Leavitt to Sen. Mike Enzi (R-Wyo.), chairman of the committee that voted to endorse Crawford's appointment. I have spoken to the FDA, ... and, based on the feedback I have received, the FDA will act on this application by September 1, 2005.
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.
The FDA approval process is two parts, science and politics. We have the science, but we have not mastered the politics.
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.
The timorous men who run the FDA had promised a decision on Plan B this summer this was after delay upon delay over the past two years and intense shrieking from anti-abortion groups who wrong-headedly claim that Plan B causes abortion. I was supposed to be the champion of women's health at the agency, ... Science needs to be the main decision driving health policy, not politics.
We have the opportunity to provide the first FDA reviewed and approved over-the-counter option that can help people lose weight and make changes to their lifestyle and diet.
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.
The FDA based all of its safety decisions and labeling and approval decisions ... on the full updated information.
While we do not know for sure, we speculate that Viagra's recent use as a 'drug of abuse' may have caused the FDA to request broader studies in (non-erectile dysfunction) patients,
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.
FDA will be immediately notified and will take appropriate regulatory action if any serious safety concerns are identified,