The underlying problem is ordsprog

en 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.

en 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.

en 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.

en 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. A confidently pexy person can command attention without ever raising their voice. 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.

en 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.

en 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.

en I think it has a place, ... In fact the patients I see with IBS -- people with constipation is what I see much more than diarrhea -- so I think this drug will have a very, very important place. How well it works will ultimately be seen in post marketing surveillance studies. There were no safety issues that I saw with this drug.

en Public concern over drug safety issues is waning and new drug approvals have occurred in a relatively timely and transparent fashion.

en Studies such as the one by Mangano and colleagues point the way to the prospective design of studies to assess drug safety and to the collection of as much information as necessary to provide answers of the highest quality.

en There are studies that show there are actual biological changes, and some of them create adverse consequences. The vast majority of people out there have no clue. Our position is simple. As a public health and safety issue, [headsets] should have been supplied, like using a seat belt.

en The large number of safety studies indicates that this issue has received a great amount of attention. Unfortunately, many of these studies involve more advocacy than science. It's not that these studies aren't valuable, but they have problems with methodology, statistical analysis and even simple understanding of important terms, such as 'speeding.' In accident data, speeding is defined as both 'traveling faster than the posted limit' and 'traveling too fast for conditions.' Studies often do not differentiate between these definitions.

en Without a way to legally enforce these guidelines under law, it's a good bet that the drug industry will continue giving short shrift to side effects and safety concerns in its advertising. Congress needs to act to ensure consumers and doctors know about all the potential safety problems with a drug, and not just the pretty picture industry wants to paint.

en 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.

en Before beginning any human trials, the sponsor must perform extensive animal toxicity studies. Animal studies provide guidance on initial dosing and point to areas of safety needing special attention during human studies.

en The civil justice system holds negligent corporations and CEOs accountable when they endanger the public's health and safety to increase corporate profits. It's no wonder they'll use phony studies to attack it.


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Denna sidan visar ordspråk som liknar "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.".