involved selling his ImClone stock and then notifying his family of the impending refusal by the FDA for the approval of their first drug Erbitux. Waksal was privy to non-public information which he knew would negatively impact the value of ImClone stock. Rather than perform his corporate duty and abide by the Securities Act‚ he made the conscious decision to deceptively sell his shares of stock before the FDA results caused him to suffer huge personal financial losses. Waksal attempted to transfer
Premium Stock Business ethics Corporate social responsibility
The company that I chose was Cryolife‚ Inc. Cyrolife was founded in 1984 as a processor of the preservation of human heart valves for adults and children that needed heart valve reconstruction (Cryolife‚ 2015). The company has expanded to provide biomedical products for cardiac and vascular products‚ surgical adhesives‚ and processed human cardiac and vascular transplants (Cryolife‚ 2015). Cyrolife is one of the few publically traded tissue processors within the transplant industry and operates the
Premium Health care Health insurance Health economics
approved drugs. This paper aims to help understand and perform the safety of drug uses. Method A literature search for articles that discuss Drug safety before‚ during‚ and after its approval was performed using PubMed and Food and Drug Administration (FDA) websites. Review articles‚ between 2000- 2009‚ related to drug safety and pharmacovigilance (detecting‚ assessing and preventing drugs side effects) were discussed to investigate the adverse effects of any drug. Results Introduction to drug safety
Premium Pharmacology Pharmaceutical industry Clinical research
Zhang 1 Lead (II‚ IV) oxide is a pigment used in lipsticks. FDA suggested that there are 400 types of lipsticks on the market contains lead. Lead is proved to be a toxic and when a pregnant woman ingests the lipstick by accident‚ the lead consumed can be passed onto the infant and might cause mental retardation to the infant. The cosmetic acknowledge the existence of the lead in lipsticks‚ but since there were no enforcements from the FDA‚ most companies chose to ignore and continue to sell the contaminated
Premium Cosmetics Lead
blamed naproxen for skewing the results against Vioxx 3) New England Journal of Medicine Omission g) Merck omits three heart attacks from article submission h) Inclusion of omitted data caused a significantly greater result 4) FDA Reaction i) Letter regarding downplay of risks j) Addition of warning label to Vioxx k) Additional study results 5) Approve Study l) Results with placebo group cause Merck to recall drug 6) Trials m) Challenge
Premium Coronary artery disease Aspirin Hypertension
chemicals in nail products comply of only having certain things expected by the Food and Drug administration(FDA). That is to say “Cosmetic products and ingredients don’t need FDA premarket approval.”(211) Thus‚ being the companies have full control of what ingredients are put into their products. Because “the law does not require the cosmetic companies to share their safety information with FDA.” (211)There is no testing needed to pass any regulations in the U.S. Not securing the safety of the products
Premium Pregnancy Uterus Childbirth
EXECUTIVE SUMMARY ImClone Systems is a New York City based firm specializing in research and development of treatments and cures of cancer. The company’s Erbitux (C-255) product was not FDA approved as of the date of this occurrence‚ though it has been released for “compassionate Use” program under the FDA regulations. This enables the company to provide treatment to patients with terminally ill circumstances‚ who have not been included in the various clinical trials which are conducted by the
Premium Cancer Clinical trial
multi-media approach is relatively new for pharmaceutical companies as previously such efforts were directed only at physicians who were the sole decision makers when choosing medications. With the 1997 change in the Food and Drug Administration’s (FDA) guidelines along with patients desires to be more involved in their own care and treatment‚ drug companies have expanded their promotional efforts to include the consumer. This essay will look at some of the current regulations concerning DTC advertising
Premium Advertising Pharmacology
Abortion Drug Kills Woman in Australia at Marie Stopes The first woman in Australia has died from a lethal infection contracted after using the deadly RU 486 abortion drug. The abortion pill has killed more than a dozen women worldwide and potential dozes of women across the globe‚ according to its European manufacturer. The woman has not been named by government officials but she received the abortion drug at a Marie Stopes International abortion facility in 2010. She contracted streptococcus
Premium Abortion
hyperactivity and other behavioral effects in children. Posing some risks‚ while serving no nutritional or safety purpose‚ Yellow 5 should not be allowed in foods. Yellow 6 caused adrenal tumors in animals‚ though that is disputed by industry and the FDA. It may be contaminated with cancer-causing chemicals and occasionally causes severe hypersensitivity reactions. Yellow 6 adds an unnecessary risk to the food supply. Almost all the toxicological studies on dyes were commissioned‚ conducted‚ and
Premium Food coloring Dye United States