U.s. Food And Drug Administration - 2538 Words

FDA’s position The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective. On the other hand, there are many patients who could not be enrolled in clinical trials because they do not fit the inclusion criteria or because the study is for a different indication. However, in these cases the patient may be able to receive the product medication under certain criteria through expanded access. Since 1987, the FDA has established rules that have enabled patients to access drugs or biologics that are still in development for treatment purposes, but the access primarily is limited to patients with cancer and HIV infection. In 2009, the FDA promulgated a program called the â€Å"expanded Access† orâ€Å"compassionate use† program ( 21 CFR 312.1) with clear regulations and procedures which provide greater access to more patients whoseShow MoreRelatedU.s. Food And Drug Administration3715 Words   |  15 Pages U.S. Food and Drug Administration Proposed Rule to Extend Its Reigns Over E-Cigarettes Abstract The Food and Drug Administration (FDA) is a division of the Department of Health and Human Services (HHS) and received its name in 1930. Although the FDA’s roots can be traced back as far as 1862, its right as a regulatory agency came into effect under the 1906 Pure Food and Drugs Act. This legislation was created to eliminate misrepresentation of food and drugs in an effort to protect theRead MoreU.s Food And Drug Administration1753 Words   |  8 PagesOn December 1, 2014 the U.S Food and Drug Administration (FDA) established two new rules requiring menu labeling and vending machine labeling. What does this mean exactly, well when it comes to menu labeling any establishment that has 20 or more chains are now required to list the calorie information on their menus or menu boards. This not only includes sit-down restaurants but also drive-through windows and takeout foods. They also established another rule for vending machines which requires allRead MoreU.s. Food And Drug A dministration 20081687 Words   |  7 Pages U.S. Food and Drug Administration 2008, FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence U.S. Department of Health and Human Services, updated 2015, viewed 13 January 2016, . Williams, S 2016, Will 2016 Be Johnson Johnson s Best Year Yet? , The Motley Fool 1995 – 2016, Viewed 6 January 2016, . Wordsworth, M 2012, Johnson Johnson to phase out potentially harmfulRead MoreSupplements : Dietary Supplements, As Defined By The Fda ( U.s. Food And Drug Administration1344 Words   |  6 PagesIETARY SUPPLEMENTS Dietary supplements, as defined by the FDA (U.S. Food and Drug Administration), are products intended for ingestion which contain any ingredients which add further nutritional value to the diet. Dietary supplements fall under the food category and consist vitamins, minerals, herbs, amino acids, metabolites, extracts (U.S. Food and Drug and Administration (FDA), 2015). Supplements are taken by many people to assist in the building of muscle and to assist in recovery after workoutsRead MoreEnsuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration4116 Words   |  17 PagesEnsuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturingRead MoreEssay Bio-engineered Processed Food1667 Words   |  7 Pagesyears, food has been increasingly changing from natural food to bio-engineered processed food. Modern civilization has changed the type of food people intake. The market has found the way to conserve and present their food in a way which attracts customers to buy them. In today’s society, companies transport food to places which were difficult before to reach in other places. In consequence, companies began to utilize chemicals and preservatives in order to aid in the maintenance of the f ood duringRead MoreFrequency Of The Radio Frequency Technology1001 Words   |  5 Pagessignals back from the tag (U.S. Food and Drug Administration, 2014). The tags use the radio waves to communicate the identity to the nearby readers and this process can be active or passive (U.S. Food and Drug Administration, 2014). Passive RFID tags are powered by readers and do not require battery. The active RFID tags are powered by batteries. The RFID tags can store a range of information from one serial number to several pages of data (U.S. Food and Drug Administration, 2014). In the healthcareRead MoreVaccines Are Safe And Safe Today1231 Words   |  5 Pagesprovided to the public. Currently the U.S. Food and Drug Administration (FDA) is responsible for protecting the over all public health of the United States of America (U.S. Food and Drug Administration, 2015). The FDA protects the â€Å"public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation† (U.S. Food and Drug Administration, 2015). On the Medical aspect, theRead MoreSafety Of Food And Drugs Consumption1448 Words   |  6 PagesSafety in food and drugs consumption is a necessity to consumers. It is the FDA s responsibility to ensure food and drug safety for the public. That’s why the FDA is what happens when agency within the U.S. Department of Health and Human Services (HHS) responsible for ensuring the safety and effectiveness. As the Food and Drug Administration Progresses it had became a reliable source for Americans .President Theodore Roosevelt signed the Food, Drug, and Cosmetic Act in 1938 to provide the publicRead More History and Laws behind the Federal Food and Drug Act of 19061232 Words   |  5 PagesHistory and Laws behind the Federal Food and Drug Act of 1906 As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would