FDA Public Health Research Articles

Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA's credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA's public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.

Public Health Risks Of Biogenic Amines From Curd Dairy Products

Biogenic amine content of cheese can be extremely variable and depends on the type of cheese, the ripening time and the manufacturing process. The amount of biogenic amines in cheese may act as a useful indicator of the hygienic quality of the product. One hundred and forty samples of different varieties of cheese represented as (Kareish, Damietta, Ras, Mish, Cheddar, Edam and Roquefort) 25 of each were collected from groceries, and supermarkets from different localities in Alexandria city for determination of Five biogenic amines including histamine, tyramine, cadaverine and putrescine and tryptamine by high performance liquid chromatography. The highest histamine mg/100 g levels were detected in the examined mish cheese followed by Ras cheese while, histamine failed to be detected in the examined Roquefort cheese. Tyramine level was detected in all examined cheese samples except Roquefort cheese and the percent of positive samples that exceeded the permissible limit of ES (2007) and FDA (2001) were 40 and 55%, respectively. All positive samples of Cheddar, Edam and Roquefort cheeses for cadaverine were within the ES (2007) permissible limit While, all positive samples of examined cheese samples were above the FDA (2001) permissible limit except Roquefort cheese. While, only one sample from of positive putrescine examined samples of Damietta, Cheddar and Edam cheese were above the permissible limit. All examined cheese samples were within the permissible limit of tryptamine level according to ES (2007) and FDA (2001) Public health hazards of biogenic amines in different cheeses and suggestion to produce high quality cheese was discussed to come in accordance with the safe permissible limit to ensure human safety.

Impact of the FDA's public health advisory for topical calcineurin inhibitors on treatment patterns in infants with atopic dermatitis

Impact of the FDA's public health advisory for topical calcineurin inhibitors on treatment patterns in infants with atopic dermatitis

All‐cause mortality associated with atypical and typical antipsychotics in demented outpatients

To estimate the association between use of typical and atypical antipsychotics and all-cause mortality in a population of demented outpatients. The study cohort comprised all demented patients older than 65 years and registered in the Integrated Primary Care Information (IPCI) database, during 1996-2004. First, mortality rates were calculated during use of atypical and typical antipsychotics. Second, we assessed the association between use of atypical and typical antipsychotics and all-cause mortality through a nested case-control study in the cohort of demented patients. Each case was matched to all eligible controls at the date of death by age and duration of dementia. Odds ratios were estimated through conditional logistic regression analyses. The crude mortality rate was 30.1 (95%CI: 18.2-47.1) and 25.2 (21.0-29.8) per 100 person-years (PY) during use of atypical and typical antipsychotics, respectively. No significant difference in risk of death was observed between current users of atypical and typical antipsychotics (OR = 1.3; 95%CI: 0.7-2.4). Both types of antipsychotics were associated with a significantly increased risk of death as compared to non-users (OR = 2.2, 1.2-3.9 for atypical antipsychotics; OR=1.7, 1.3-2.2 for typical antipsychotics). Conventional antipsychotic drug should be included in the FDA's Public Health advisory, which currently warns only of the increased risk of death with the use of atypical antipsychotics in elderly demented persons.

FDA's public health goals in evaluating health claims.

Scientific developments have increased awareness of possible links between diet and health within the scientific community and in the general public and have generated interest in the use of disease-related health claims on food labels. The enactment of the Nutrition, Labeling, and Education Act for the first time authorizes such claims if they are claims approved by FDA. From FDA's perspective, it is imperative that statements regarding potential health benefits of changes in nutrient intake also take into consideration potential health risk. The ultimate goal must be to capitalize on available scientific evidence and the communication capacity of the food label to assist the consumer in constructing healthier diets.