"We are moving as quickly as possible, " says Peter Suzdak, senior vice president for research at Guilford, although no human trials have begun.
But the new law included a loophole called 510(k) that remains today: A device can be approved with few or no clinical trials if it is deemed "substantially equivalent" to a gadget that existed before 1976.
There have been no clinical trials to assess the effect of higher doses, although two other studies done on less-sick patients might suggest the higher doses are problematic--one in 1998 for patients with cardiac disease and one last year for chronic kidney disease patients.
While Vivus registered four Stage III clinical trials with the government registry, no study results from any of those trials have been published, though presumably preliminary data were submitted to the FDA panel.
FORBES: New Diet Drug Qnexa Promises 10% Weight Loss - At What Price?
He figured that smallish trials with no control group too often yield ambiguous data.
Doctors and politicians want more transparency, meaning no sweeping of disappointing trials under rugs.
There's also no proof from randomized trials that more frequent treatment saves lives or prevents hospitalizations.
In some trials, no honest scientist would be able to say that the data supports either side.
Animal tests show that the compound does indeed hit the autoreceptors, and early human trials found no big safety problems.
These trials found no difference in breast cancer deaths after 15 years between women who regularly self-examined and women who did not.
"For the four others investigated, there are no published randomised clinical trials to support their efficacy in weight loss, " Dr Cable added.
But the AHA fails to note that there have been no big randomized clinical trials with hard outcomes that show the benefit of their diet.
Although the commercial preparations employed in the trials are no cheaper than imported organophosphates, a source of the mineral has recently been identified in Zimbabwe.
No matter what future clinical trials show, Arimidex will never fully replace tamoxifen.
Ace the diabetes trial, with at least as much effectiveness as shown in previous trials, with no hints of new safety problems.
And the company says big clinical trials it conducted show no cardiovascular risk.
Prior to these trials, there was no signal about the risk of diabetes.
However, Pfizer has said there were no reports of NAION in the trials of the drug carried out before it was licensed.
With so much at stake I was surprised that there had been no prospective, placebo-controlled trials conducted that were funded by an independent source.
Dry runs and simulations are no substitute for real-world trials.
ECONOMIST: What kind of industry asks its regulator to block all deals?
There was no proof it would help (trials are under way at Stanford, partly sponsored by the SMA Foundation), but it had been safely used before on kids with sickle-cell anemia.
There are no opening speeches in Scottish criminal trials, presumably to avoid the risk that juries will decide cases on the strength of what's alleged rather than what can be proved.
So far officials of the National Institutes of Health say they've seen no serious side effects in clinical trials and that study subjects who have been immunized have generated a good response.
He said there was usually no point trying dead people because trials are about punishment and involve a process of interaction with the accused, including the accused's ability to defend him- or herself.
More common are promising molecules that flunk clinical trials and so earn no return at all, or drugs that shine for a few months before being trounced by a better pill from a rival firm.
And there is no guarantee that any vaccine currently in trials will make it to patients.
They had Mr Elmore testify, a rarity in murder trials, and they called no other witnesses.
ECONOMIST: Capital punishment in America: Justice, delayed and denied | The
应用推荐