This situation illustrates the difficulties in navigating an uncertain regulatory environment. 3. It is reasonable that the WHO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded t 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 TRUTH The Truth about the Undeniable Hypocrisy of the FDAHow can one trust the daily supplement, hormone replacement, or pharmaceutical intervention that could be ingested with the political or pharmaceutical agenda? There is a need for the Food Continue Reading...
Thalidomide Although the United States succeeded in averting the same thalidomide tragedy that occurred in Europe by refusing to approve the drug, some observers counter that the action introduced unnecessary delays in the approval of many useful d Continue Reading...
oecd.org/document/24/0,3343,en_2649_34537_1885208_1_1_1_1,00.html http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm http://usbiotechreg.nbii.gov / http://www.library.ca.gov/crb/96/07/BIOT_CH3.html http:// Continue Reading...
Fluoxetine (Prozac) Since its approval for use in the United States by the FDA in 1987, fluoxetine (commonly known as Prozac) has been the subject of great debate. Fluoxetine, now available in generic form, has been proven useful in the treatment of Continue Reading...
Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while compe Continue Reading...
Cancer Drugs For the past several decades, the news about cancer in the United States has been increasingly positive and that trend has continued unabated over the past decade. According to the National Cancer Institute at the National Institutes o Continue Reading...
Marketing Considerations Marketing in the biotechnology industry is critically important. The basic path to market involves receiving regulatory approval for products. From there, marketing is conducted to physicians directly, necessitating a rela Continue Reading...
Devices for the Future Device Description Brain controlled prosthetics that have been designed so well that they are almost natural, are the focus of this paper. These limbs enabled humans to figure out how to move them in similar ways as they woul Continue Reading...
FDA Drug Approval Process In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $ 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...
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...
True that the existence of both which is intended for a similar use, operation or treatment might cause confusion and a question on which is a better product. In this case the replacement of Imigran with the new medication Naramig was the best choic Continue Reading...
This relationship has an effect on the payment rates that CMS sets. Higher cost pharmaceutical therapies are systematically reimbursed below acquisition cost (i.e., the payment system is biased against full reimbursement for higher cost therapies). Continue Reading...
According to these authors, the fatal tragedy could easily have been avoided by taking more time for more focused and carefully planned clinical trials. According to this view, it was unethical to test Tysabri in the way it has been done, and furthe Continue Reading...
Sexual Liberation In addition to sexual intercourse and its variations, sexual liberation refers to the universe of human issues affecting all genders. America was propelled from the sexual enslavement of the 1950's to considerably increased sexual Continue Reading...
The healthcare costs associated with major depression are astronomical. Compared to antidepressants, costs for treatments with NeuroStar are economical. One session is expected to cost approximately $400 per treatment session, with typical patient n Continue Reading...
" Concerning the type of complementary strategic alliance, it is a horizontal one, because it is formed "when partners who agree to combine their resources and skills to create value in the same stage of the value chain," it is focused "on long-term Continue Reading...
What is worth noting here is the fact that behavior disturbances, ranging in severity from repeated questioning to physical violence, are common (National Institute of Mental Health, 1989). It is unclear whether Alzheimer's disease represents a sin Continue Reading...
Marketing Product Safety, And Intellectual Property Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Ethics and legal issues refer to the morals and principles that govern the behavior and conduct of individuals or Continue Reading...
Business Law During the consumer movement of the 1960s and 1970s, Congress enacted a substantial amount of legislation to protect "the good of the people." There is only one problem with consumer protection laws -- they are slow to react and even ha Continue Reading...
New communication technologies require stricter scrutiny, as well. The threat of reprisal is the most effective measure against intellectual property right infringements, and for this reason one of the most essential actions that can be taken in thi Continue Reading...
These are called inclusion/exclusion criteria, and not only protect the participants from harm but also allow the researchers to be sure that the studies they do provide reliable data on the safety and efficacy of the drug. Each person who takes par Continue Reading...
76), ROE has ranged from 21.6% to 28.3% in recent years, with the 2007 figure being 25.6%. This reflects outperformance of both the industry and the market. The ROA has exhibited similar outperformance of both industry and market. The return on asse Continue Reading...
Parkinson's disease is a malady that all people should be afraid of because of the fact that it generally chooses its carriers randomly. Also, once having contracted the disease, people should not lose their hope, with numerous people having lived Continue Reading...
In Germany it is still an offence under the drug laws to posses the drug but the laws are some what more liberal. For example the prosecution may not press charges where the drug was found to be in 'low quantity 'and was for personal use. Thus patie Continue Reading...
Figure 1 portrays three of the scenes 20/20 presented March 15, 2010. Figure 1: Heather, Rachel, and Unnamed Girl in 20/20 Program (adapted from Stossel, 2010). Statement of the Problem For any individual, the death of a family member, friend, pa Continue Reading...
Human Papilloma Virus Vaccine Human Papilloma Virus The paper deals with HPV epidemiology and associated diseases, the licensed HPV vaccines, recommendations of ACIP, concerns on mandating the HPV vaccine among young girls and the personal perspect Continue Reading...
Organics trip to the local grocery store will reveal that organic vegetables and fruits not only look better than their non-organic counterparts: they are in many cases also not that much more expensive. As a result, many mainstream supermarkets are Continue Reading...
Angiomax Case Analysis Will the Angiomax product be a low or a high priced product? Why? Given the concepts and frameworks as defined by Dolan and Gourville in their accumulated research on pricing, it is clear the Angiomax product will be able to Continue Reading...
Childhood Obesity in America The authorities can only address the issue of childhood obesity by educating people on the negative effects that the condition imposes, because only then can they get everyone, whether personally affected or not, aboard, Continue Reading...
4 months in the placebo group. (P=0.01) [Kyogo et.al] an earlier study by Nestle et.al (1998) had showed promising results. In that study, a small group of renal cancer patients were vaccinated with RNA-transfected dendritic cells. T cell response wa 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...
Japanese-American Biopharmaceutical Industry in the 21st Century Optimizing Ethical Drug Availability Between These Two Pharmaceutical Superpowers" The Japanese-American biopharmaceutical industry represents an ongoing international effort betwee Continue Reading...
Introduction The NIH (2014) defines robotic surgery as "a method to perform surgery using very small tools attached to a robotic arm", wherein the surgeon operates the robot. Robotic surgery was developed to enable the performance of Continue Reading...
Insider Trading On June 4, 2003, the Securities Exchange Commission announced that it was pursuing charges against investor Martha Stewart and stock broker Peter Bacanovic for securities fraud. The fraud occurred on December 27, 2001 when Stewart so Continue Reading...
Wyeth may have been prescient in recognizing the need to break the mold in pharmaceutical research: the old model of heavy, expensive and long research projects (with a concomitant high rate of failure) needed to be addressed. Also, the earlier emph 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...
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...
