Furthermore, of the seven studies the FDA did make note of, all but the smallest study found marked increased risks of fractures.

Nearly half ( 42 %) of these prescriptions were for conditions not approved by the FDA, such as acute bronchitis, otitis media, and acute upper respiratory tract infection, according to a study supported in part by the Agency for Healthcare Research and Quality.

Although phenytoin was not named in the study, the FDA announced that it expected the risk applied to every epilepsy drug.

Following FDA clearance, an independent randomized controlled study, sponsored by the United States National Institute of Mental Health ( NIMH ), was conducted utilizing the NeuroStar TMS Therapy System ( clinicaltrials. gov identifier: NCT 00149838 ).

In January 2007 an advisory panel of the United States Food and Drug Administration ( FDA ) did not recommend clearance for marketing of an rTMS device, stating that the device appeared to be reasonably safe but had failed to demonstrate efficacy in a study of people with major depression who had not benefitted from prior adequate treatment with oral antidepressants during their current major depressive episode.

The authors were sharply criticized by Bernard Carroll, a one-time chairman of the FDA Psychopharmacological Drugs Advisory Committee, for presenting these results as positive: " The study has all the hallmarks of an ' experimercial ,' a cost-is-no-object exercise driven by a corporate sponsor to create positive publicity for its product in a market niche.

An FDA study found more in boiled spinach in the early 90's ( 0. 125 mg / kg ) than in the 320 other foods studied.

The settlement required GSK to post a registry which would include much more information about pretrial and clinical drug study results than what the U. S. Food and Drug Administration ( FDA ) and other pharmaceutical companies had thus far been willing to make public.

In the US, the FDA can audit the files of local site investigators after they have finished participating in a study, to see if they were correctly following study procedures.

Dapoxetine is currently waiting for U. S. Food and Drug Administration ( FDA ) approval after concluding the Phase III study, which included participants from 25 other countries, including the United States.

In 1973, in an attempt to restrict off-label use of DES as a postcoital contraceptive ( which had become prevalent at many university health services following publication of an influential study in 1971 in JAMA ) to emergency situations such as rape, an FDA Drug Bulletin was sent to all U. S. physicians and pharmacists that said the FDA had approved, under restricted conditions, postcoital contraceptive use of DES.

A class action suit has been filed against Biovail by investors who between December 14, 2006, and July 19, 2007, bought Biovail stock, alleging that the company had failed to disclose that the multi-dose study on depression drug Aplenzin would not be sufficient for the FDA to approve it.

When removing the olestra warning label, the FDA cited a six-week P & G study of more than 3000 people showing the olestra-eating group experienced only a small increase in bowel movement frequency compared to the control group.

A study in 1994 of radiation induced skin injuries has been performed by the Food and Drug Administration ( FDA ) followed by an advisory to minimize further fluoroscopy-induced injuries.

In the same study, HandClens was shown to meet and exceed the FDA performance standards.

Summarizing the substantial and growing body of study results showing deleterious health effects of breathing ozone, in 1976, and reiterated in 2006, the United States Food and Drug Administration ( FDA ) reflects the scientific consensus that ozone is a toxic gas which has, as yet, no demonstrated safe medical application in specific, adjunctive, or preventive therapy.

* SAS 5 Transport files (. XPT ) as required by the Food and Drug Administration ( FDA ) for New Drug Application ( NDA ) study submissions

In one study, pyridoxamine was more effective at protecting from ionizing radiation-induced gastrointestinal epithelial apoptosis than amifostine ( the only radioprotector currently Food and Drug Administration ( FDA )- approved ) due to pyridoxamine reactive oxygen species and reactive carbonyl species scavenging profile.

This practice is sanctioned by the FDA as necessary emergency research, but patients ’ rights groups protested the study.

One major exception is the Shelf Life Extension Program ( SLEP ) of the U. S. Department of Defense ( DoD ), which commissioned a major study of drug efficacy from the FDA starting in the mid-1980s.

One criticism is that the U. S. Food and Drug Administration ( FDA ) refused to issue guidelines based on SLEP research for normal marketing of pharmaceuticals even though the FDA performed the study.

* Topiramate ( Topamax ) is not FDA approved for bipolar disorder, either ; and a 2006 Cochrane review concluded that there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness.

concluded, “ Patients receiving a silver-coated endotracheal tube had a statistically significant reduction in the incidence of VAP and delayed time to VAP occurrence compared with those receiving a similar, uncoated tube .” In addition, the U. S. Food and Drug Administration ( FDA ) has recently approved an endotracheal tube with a fine coat of silver for use in mechanical ventilation, after studies found it reduced the risk of ventilator-associated pneumonia.

The FDA concluded that they were dealing with a " fraud of the first magnitude.

Given the small number of NAION events with PDE5 use ( less than 1 in 1 million ), the large number of users of PDE5 inhibitors ( millions ) and the fact that this event occurs in a similar population to those who do not take these medicines, the FDA concluded that they were not able to draw a cause and effect relationship, given these patients underlying vascular risk factors or anatomical defects.

At the time of the 1996 ruling, FDA concluded that, “ to avoid being misbranded … olestra-containing foods would need to bear a label statement to inform consumers about possible effects of olestra on the gastrointestinal system.

The FDA concluded the label statement was no longer warranted ", in spite of having received over 20, 000 complaints.

The FDA concluded that “ subjects eating olestra-containing chips were no more likely to report having had loose stools, abdominal cramps, or any other GI symptom compared to subjects eating an equivalent amount of chips .”

The FDA experts concluded that " Duloxetine can cause hepatotoxicity in the form of transaminase elevations.

In April 2005, after an extensive review of data, the FDA concluded that it was likely " that there is a ' class effect ' for increased CV risk for all NSAIDs ".

A 2004 systematic review conducted by the Life Sciences Research Office, whose clients include the FDA and NIH, concluded that " the current data are insufficient to support an association between mercury release from dental amalgam and the various complaints that have been attributed to this restoration material ".

The FDA concluded its revision on April 6, 2005: the final document can be found here.

In the United States, the Food and Drug Administration ( FDA ) concluded in August 1971 that lead tinsel caused an unnecessary risk to children, and convinced manufacturers and importers to voluntarily stop producing or importing lead tinsel after January 1, 1972.

The Court therefore concluded that Congress did not intend to give the FDA the power to regulate tobacco, and that the regulations were therefore invalid.

" The Food and Drug Administration ( FDA ) investigated and concluded that banana skins were not psychedelic.

" The company hopes that after the use of the compound in treating a high-risk acute condition is approved and well-established, the risks of longer-term use at higher doses, such as for treatment of ADHD, will be shown to be less than the FDA had concluded.

FDA studies had concluded that HCP caused brain damage in infants, and ordered immediate removal of baby powder with more than 0. 75 % HCP, and directed that cleansers with 3 % concentration could be sold only by prescription.

In 2008 the FDA analysed their data again and confirmed an increased rate of cancers in the randomised trials compared to placebos but concluded that the rate of cancers did not warrant any regulatory action.

A Food and Drug Administration ( FDA ) investigation concluded that the scientists involved in the trial, including the co-investigator Dr. James M. Wilson ( Director of the Institute for Human Gene Therapy ), broke several rules of conduct:

However, due to a series of birth-defect lawsuits in the United States against its maker, Merrill Dow, Bendectin is not currently on the market in the U. S. ( None of the lawsuits were successful, and numerous independent studies and the Food and Drug Administration ( FDA ) have concluded that Bendectin does not cause birth defects.

The FDA further stated in 2003 that "... A reduction in awareness provides a public health benefit, in that BIS technology can now provide anesthesiologists with a way to reduce this often debilitating, yet preventable medical error ".

The FDA defines a covered study as "... any study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective ( including studies that show equivalence to an effective product ) or any study in which a single investigator makes a significant contribution to the demonstration of safety.