111 Search Results for FDA Center for Drug Evaluation and Research
FDA: Center for Drug Evaluation and Research (CDER)
And Over-the-counter Weight Loss Medications
Obesity is one of the most serious epidemics facing the American public. "Over two-thirds of adults in the United States are overweight or obese, and o Continue Reading...
Divisions of the FDA
The FDA is in charge of the regulation of pharmaceutical drugs and medical devices, as part of its mandate to safeguard the U.S. health care system. One unit for this is the Center for Devices and Radiological Health (CDRH), whi Continue Reading...
Rats are commonly used for their size (creating the animal-sized scanners is so expensive they are commonly not used in veterinary medicine even for dogs and cats) and the fact that rats breed quickly (PET, 2011, New World Encyclopedia). Lab rats ha Continue Reading...
Gene Therapy
FDA
Ethics can be considered to come from personal values. From both a medical and a business perspective, ethics are the reasons that some news stories should be followed from beginning to end and all in between. "On Sunday morning, 2 Continue Reading...
Administrative Law
REGULATING STEM CELL THERAPY
Administrative Agency: Food and Drug Administration
Article 1 Section 1 of the federal Constitution creates administrative agencies, which are law-making entities but with limited powers (USLegal, 20 Continue Reading...
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for Continue Reading...
The use of pharmacotherapy, including nicotine replacement therapy (NRT), has been shown to increase the likelihood of a successful quit attempt. Smoking cessation has numerous health benefits, including an increase in longevity, even among smokers Continue Reading...
Patient care and recovery statistics demonstrate that the United States has a medical care system with which Americans are less satisfied than other citizens in developed countries. There are many reasons for this: correlation between health and soci Continue Reading...
...It can spot moderate to severe dysplasia (irregular tissue), "some of which may turn out to be malignant and you'll have a case of lung cancer," he explains. Patients with dysplasia can then be closely monitored, and if cancer appears, it can be t Continue Reading...
Applying Statistical Process Control Pharmaceutical Manufacturing
The use of applied statistics in studying a pharmaceutical manufacturing process is examined in the work of Tiani (2004) reports that health care quality is critically important in so Continue Reading...
Generics, Biologics, and Biosimilars
Properties of Generic Drugs, Biologics, and Biosimilars, with Examples and Usage
Generic drugs
Generic drugs denote pharmaceutical products that are typically meant to be substituted with some innovator product Continue Reading...
Pharmacy Practice in the United States
From its very beginnings, pharmacy was considered the art of making medicines. Like most arts that originated in earlier times, it came eventually to be regarded as a science in the modern age (Wutoh 2). Throug Continue Reading...
(Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 8)
Results from this study relate a moderate quality evidence that aerobic-only exercise training at recommended intensity levels produces positive effects "global well-being (SMD 0.44, 95% c Continue Reading...
Marketing Plan for Kaiser Permanente
Part A
For nearly three-quarters of a century, Kaiser Permanente (hereinafter alternatively “Kaiser” or “the company”) has provided quality health care to a growing number of customers (Abo Continue Reading...
Health Science in Regards to Drugs and Alcohol
Legalization of drugs
When Colorado and Washington legalized the use of marijuana for recreational purposes, issues related to legalization of all drugs became subject of public debate. Those who voted Continue Reading...
Direct to Consumer Advertising
HISTORY OF DRUG ADVERTISING
THE DTC ADVERTISING PHENOMENON
CREATING DEMAND
DECEPTIVE ADVERTISING - A WOLF IN SHEEP'S CLOTHING
CAUSE OF DEATH
PROFIT
UTILIZATION, PRICING, AND DEMOGRAPHICS
LEGISLATION, POLITICS AN Continue Reading...
However, what was once a slow journey has recently gathered momentum with the introduction of "more flexible immunosuppression protocols, the ability to individualize surgical options to patient needs, and the dramatic improvement of isolated islet Continue Reading...
I have a clear written mandate that guides this decision. The other alternatives do not have the same clear, written mandate as the one that I made. While a utilitarian approach may have yielded a different decision, in my position as a safeguard of Continue Reading...
Each of these consultative bodies is made up of ten to fifteen doctors and scientists with widespread knowledge about infectious illnesses, immunology and vaccine research. The statistics measured by these groups are wider than that looked at by the Continue Reading...
Offshoring
Country selection: China
China, undeniably, represents one of the best markets to perform a clinical trial. It is home to the largest global urban population, and provides an extensive patient pool as well as a vast network of hospitals. Continue Reading...
Research risk management programs for health care facilities or organizations
· Introduction
Healthcare risk management entails the administrative and clinical processes, systems and reports applied for the purpose of detecting, assessing, mon Continue Reading...
Drug Development (From Nature to the Market)
The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve nu Continue Reading...
" (1999) Moran states that it has been demonstrated in many studies that a "familial aggregation f risk factors for obesity exist and the family "provides the child's major social learning environment." (1999)
Surgical and Pharmacological Treatment
Continue Reading...
Economic Evaluation in Drug Development
Which form of economic evaluation might be appropriate to assess whether a new me-too drug is cost-effective
Me-too drugs are drugs that are anatomically and physically very comparable to drugs that are alrea Continue Reading...
Audit of Organizational Effectiveness
Department of Social Services
Effectiveness audit: The Department of Health and Human Services
Organization to be analyzed
The Department of Health and Human Services is the umbrella organization within the U Continue Reading...
Translating Biomedical Innovation / Mental Health and well being
Managing Ideas: Commercialization Strategies for Biotechnology
This article by Joshua and Scott Focuses on the commercialization aspect of biotechnology and stresses how important it Continue Reading...
Taken in isolation, some of the new, minimally-invasive procedures are less expensive by far, when analyzed on a procedure-by-procedure basis, than previous significant surgical interventions, as demonstrated below:
Procedure
Cost
Estimated durat Continue Reading...
One possible explanation for the differences observed in the studies could be that the strengths of the chlorhexidine solution were different. It could also be that over time more effective techniques have been developed in the application of the so Continue Reading...
The earthquake caused a landslide which cut of the inhabitants of the village from the outside world. The people of this remote village were isolated for sixteen days without food except for small amounts of rice and herbs before being rescued by mi Continue Reading...
Global Health & HIV
Global Health Issue
It is a small World: HIV / AIDS and Global Health
It is a small World: HIV / AIDS and Global Health
The purpose of this essay is to discuss in detail the HIV / AIDS issue and its different aspects and i Continue Reading...
Bisphenol-A
The organic compound Bisphenol-A, often abbreviated as BPA, is used to make polycarbonate plastic and epoxy resins. In the past, it was used primarily as a clear, strong plastic which was most often utilized in products such as baby bott Continue Reading...
Standards
Technology Impact on Clinical Research and the Interrelationship of Uniform Data Format Standards
With increasing robustness of technology, clinical programmers began realizing inefficiencies in metadata and recreation from scratch each Continue Reading...
The company needs to frame the heart complication as one that is rare. Instead of apologizing, the company needs to stand by its products and assert its commitment to safety. When the company issues its warning, the commitment to safety will be evi Continue Reading...
Health Threat of Medical Ionizing Radiation
Impact of Nuclear Medicine Exposures
In October 2009, the U.S. Food and Drug Administration (FDA) alerted all healthcare facilities involved in performing brain perfusion computed tomography (CT) to ensur Continue Reading...
, 2006). The evidence reflects only a low level weight loss but is still worthwhile to consider in controlling weight at roughly 0.007 kg per week. It is useful for individual weight loss programs. Losing 0.2 kg per week requires a decrease of 220 ki Continue Reading...
Tissue Tracking and Patient Safety
Tissue Tracking
Systemic Tissue Tracking Deficiencies Remain a Serious Threat to Patient Safety
Systemic Tissue Tracking Deficiencies Remain a Serious Threat to Patient Safety
The Joint Commission established st Continue Reading...
In the case of breast augmentation, the parent must guide the minor to the right decision -- and that is usually not to have the surgery unless it is necessary for the teen's overall health. It is up to the adult to think responsibly. There are dang Continue Reading...
P&G is looking to make the Supplier Environmental Sustainability Scorecard methodology a global standard (P&G, 2010). To support this effort to make the scorecard a global baseline of sustainability measurement, P&G freely distributes Mi Continue Reading...