In 2009 the US Food and Drug Administration said it halted reviews of all drug applications including data developed at Ranbaxy's Paonta Sahib Plant in India because of a practice of falsified data and test results in approved and pending drug applications. In…
potential. This Act made these drugs illegal to use. When deciding whether to…
The pharmaceutical and medications industry regarding the amount of time and money invested in developing new drugs is one of the fastest growing industries in the United States. There are always a lot of researches, developments, and productions of new drugs in the industry of pharmaceutical; however, patients are able to find or get the medications either over the counter in a retail stores, pharmacies, and many other medical markets or by prescriptions. Consequently, medication usage is to…
Are exorbitant prices for prescription drugs a contributing factor to the high mortality and morbidity rates among Americans patients? Sometimes I often wonder if the issue of one’s inability to pay for their needed meds to get well is the result of some patients dying prematurely, more so, than the actual sickness or disease. As a result of these high prices for prescription drugs, some patients are taking risky measures by not taking their medicines as prescribed. According to the Center for…
"Achilles Heel" that is the Food and Drug Administration In Greek mythology, Achilles was a great warrior who did many great deeds. He was extremely strong and his enemies eventually came to fear the very mention of his name. Although strong, Achilles had a massive weakness that eventually proved fatal once it was exploited. In modern times, we now refer to a great weakness amidst great strength as an "Achilles Heel". The Food and Drug Administration oversees the nation 's food supply and…
Historians have referred the 1920’s as “The Roaring Twenties,” the “Jazz Age,” and the “Age of Normalcy.” Each of these labels imply different things. America in the 1920’s had a very diverse population. With a diverse population comes variegated cultural, social, political, and economic differences. However, these differences created a unified theme. The theme was change. There were political, consumer, social, and cultural changes in America through the 1920’s that exemplified this theme. The…
of consumers from food and drug products brought about the creation of the Food and Drug Administration (FDA). Since 1906 the FDA has played a key role in regulating essential products such as seafood, vegetable produce, food, additives, drugs, and even tobacco products to some extent. Programs like HACCP (Hazard Analysis Critical Control Point) ensures food safety through verification procedures throughout production. For drug regulation, the FDA put in place a thorough drug testing procedure…
In the field of biomedical research there many imperative careers that work together to reach a desired conclusion. One of these careers is a regulatory affairs specialist. Regulatory affairs specialists are a crucial part in ensuring that a client’s product meets the standards set up by various governments. Regulatory affairs specialists are needed in many biomedical industries, one of which is the pharmaceutical industry. A regulatory affairs specialist in the pharmaceutical industry has…
The peer-reviewed article, EpiPen price hikes comes under scrutiny, by Rita Rubin reports the out lash towards the drug company Mylan and CEO of Mylan Pharmaceuticals, Heather Bresch, during recent years due to the increased price of EpiPen. “… since the drug company Mylan acquired EpiPen in 2007, its price has soared more than 400%, to just over US$600.” For many Americans, the fear of losing a loved one simply because they can no longer afford the medication is very real, as according to the…
companies and through their Center for Biologics Evaluation and Research (CBER), have increased the surveillance of gene therapy clinical investigators and their studies in recognition of the potential dangers of gene therapy study (Sibbald, 2001; US Food and Drug Administration, n.d.). Lessons from Jesse’s death continue to spill over to other research areas, particularly the more recent CRISPR gene-editing…