Comparison of the Reveal Test, the U.S. Food and Drug Administration Culture Method, and Selective Media for Recovery of Salmonella Enteritidis from Commercial Egg Layer Flock Environments

2006 ◽  
Vol 69 (11) ◽  
pp. 2766-2769 ◽  
Author(s):  
LEI ZHANG ◽  
ZHINONG YAN ◽  
ELLIOT T. RYSER
Keyword(s):  
Drug Administration ◽  
Environmental Samples ◽  
Salmonella Enteritidis ◽  
Food And Drug Administration ◽  
Culture Method ◽  
The United States ◽  
Effective Control ◽  
Simple Method ◽  
Significant Difference ◽  
Administration Culture

Salmonella is the leading cause of foodborne illnesses in the United States, and Salmonella Enteritidis (SE) is the second most frequently isolated Salmonella serovar. Egg products are most often associated with outbreaks of SE infection. To prevent SE contamination of eggs, many producers are implementing flock inspections for SE at their facilities. A rapid and simple method for detecting SE in poultry environmental samples is critical for effective control of SE. In this study, the Reveal test for SE was compared with the conventional U.S. Food and Drug Administration (FDA) culture method for detecting SE in naturally contaminated environmental samples. The efficacy of two enrichment media, tetrathionate broth (TT) and Rappaport-Vassiliadis medium (RV), and three selective plating media, brilliant green agar with novobiocin (BGN), xylose lysine tergitol 4 agar (XLT4), and bismuth sulfite agar (BS), also were compared for SE isolation. One hundred twenty-eight environmental drag swab samples were collected from two previously identified SE-positive chicken flocks in two U.S. states and analyzed in parallel using the Reveal test and the FDA culture method. Twenty-five samples (19.5%) yielded SE when the Reveal test was used, and 23 samples (18.0%) were positive for SE by the FDA culture method. No significant difference in efficacy (P = 0.527) was found between the two methods. The Reveal test had a sensitivity, specificity, and accuracy of 83, 94, and 92%, respectively. Overall, a significantly greater number of positive samples was obtained after enrichment in RV compared with TT. XLT4 and BGN were more efficient than BS for isolating SE. However, no single method or medium successfully recovered SE from all SE-positive environmental samples.

Publication statuses of clinical trials supporting immune checkpoint inhibitors recently approved by the United States Food and Drug Administration: A meta-epidemiological investigation.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 89-89
Author(s):  
Kenji Omae ◽  
Yuki Kataoka ◽  
Yasushi Tsujimoto ◽  
Yusuke Tsutsumi ◽  
Shunichi Fukuhara ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Drug Administration ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Food And Drug Administration ◽  
The United States ◽  
Publication Rate ◽  
Significant Difference

89 Background: The low trial publication rate for drugs approved by the U.S. Food and Drug Administration (FDA) and the discrepancies between data submitted to the FDA and data found in published trials remain concerning. We investigated the publication statuses of trials of recently approved anticancer drugs documented by the FDA, especially immune checkpoint inhibitors (ICPis), to determine the discrepancies between data submitted to the FDA and those published. Methods: We identified all ICPis approved between 2011 (the year the first ICPi was approved by the FDA) and 2014 (selected to assure a follow-up of at least 3 years post-approval). We assessed the clinical trials for each drug indication and matched each trial with publications in the literature. The primary outcome was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model, adjusted for clustering within drug indications and individual covariates. Results: Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55); however, non-ICPIs investigated specifically in randomized phase 2 or 3 trials were significantly more likely to be published earlier than ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusions: One in three trials of the newest anticancer drugs remained unpublished 2 years after FDA approval. The ICPi publication rate was similar to that of other anticancer drugs. (Protocol registration: UMIN000030475).

Fatal and serious complications associated with cosmetic suction lipectomy

2002 ◽  
Vol 10 (2) ◽  
pp. 69-74 ◽  
Author(s):  
S Lori Brown ◽  
Janos T Bacsanyi ◽  
Sherry L Purvis-Wynn
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Cosmetic Surgery ◽  
Medical Literature ◽  
Food And Drug Administration ◽  
The United States ◽  
Physician Training ◽  
Fatty Tissue ◽  
Potential Risk Factors ◽  
Causes Of Deaths

Liposuction is the most commonly performed cosmetic surgery procedure in the United States. The medical devices and drugs used in the performance of liposuction are regulated by the Food and Drug Administration. Serious liposuction-related complications, including death, are reported in the literature. A review of reported complications and causes of deaths related to liposuction is presented. Prospective studies examining potential risk factors for complications, such as amount of fatty tissue removed and extent of body surface area affected, concomitant surgeries, method of anesthesia, impact of physician training and site of surgery, are needed to clarify the risks involved in liposuction. Studies are required to establish the risk-benefit profile of this procedure to allow patients and physicians to be adequately informed. Adverse events have been under-reported to the Food and Drug Administration despite numerous reports in the medical literature of serious complications associated with the use of medical devices in the performance of liposuction.

scholarly journals Should Graphic Warning Labels Proposed for Cigarette Packages Sold in the United States Mention the Food and Drug Administration?

2020 ◽  
Author(s):  
Mia Jovanova ◽  
Chris Skurka ◽  
Sahara Byrne ◽  
Motasem Kalaji ◽  
Amelia Greiner Safi ◽  
...  
Keyword(s):  
Middle School ◽  
Tobacco Control ◽  
Drug Administration ◽  
Source Credibility ◽  
Food And Drug Administration ◽  
The United States ◽  
Smoking Prevention ◽  
Warning Labels ◽  
The Us ◽  
Graphic Warning

Abstract Introduction Under the US Family Smoking Prevention and Tobacco Control Act, the US Food and Drug Administration (FDA) has the authority to implement graphic warning labels (GWLs) on cigarette packages. Neither the original labels proposed by the FDA nor the revised labels include a source to indicate sponsorship of the warnings. This study tests the potential impact of adding a sponsor to the content of GWLs. Methods We recruited adult smokers (N = 245) and middle-school youth (N = 242) from low-income areas in the Northeastern US. We randomly assigned participants to view one of three versions of the original FDA–proposed warning labels in a between-subjects experiment: no sponsor, “US Food and Drug Administration,” or “American Cancer Society” sponsor. We tested the effect of varying sponsorship on source attribution and source credibility. Results Compared to unsponsored labels, FDA sponsorship increased source attributions that the FDA sponsored the labels among both middle-school, largely nonsmoking youth and adult smokers. However, sponsorship had no effect on source credibility among either population. Conclusions We found no evidence that adding FDA as the source is likely to boost source credibility judgments, at least in the short term; though doing so would not appear to have adverse effects on credibility judgments. As such, our data are largely consistent with the Tobacco Control Act’s provisions that allow, but do not require, FDA sponsorship on the labels. Implications This study addresses the FDA’s regulatory efforts by informing the possible design and content of future cigarette warning labels. Our results do not offer compelling evidence that adding the FDA name on GWLs will directly increase source credibility. Future work may test more explicit FDA source labeling and continue to examine the credibility of tobacco message content among high–priority populations.

Trajectories of Injectable Cancer Drug Costs After Launch in the United States

2018 ◽  
Vol 36 (4) ◽  
pp. 319-325 ◽  
Author(s):  
Noa Gordon ◽  
Salomon M. Stemmer ◽  
Dan Greenberg ◽  
Daniel A. Goldstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Steady Increase ◽  
Drug Prices ◽  
The Us ◽  
The Mean ◽  
Over Time

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, −14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, −16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.

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