The Use Of Fda Regulation Of Drug Industry And Its Impact...

INTRODUCTION Human drugs are regulated by the U.S Food and Drug Administration (FDA). One of the first legislation which authorized FDA to regulate drugs was â€Å"Pure Food and Drugs Act† enacted in 1906. In last century, role of FDA has significantly increased in terms of regulation and supervision of drugs to promote and protect public health. The historical evolution of FDA regulation of the drug industry and its impact on marketing unapproved drugs will be discussed later in this memorandum. The term â€Å"drug† is defined means â€Å"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man† by â€Å"affecting the structure or any function of the body of man.† In order to be marketed, â€Å"new drug† needs to have an approved application. â€Å"New Drug† can be defined as â€Å"any drug†¦the composition of which is such that such drug is not â€Å"generally recognized as safe and effective† for their labelled use. Prescription drug are prescribed by a physician, usually bought at pharmacy, prescribed for and intended to be used by one person and regulated by FDA through the New Drug Application (NDA) process. A typical NDA approval process includes three clinical phases which are distinct in terms of number of patients, length of study and purpose. The new drug application approval process helps in maintaining certain safeguards such as drug safety, dosing, manufacturing quality control standards, review of ongoing clinical safety and efficacy data,Show MoreRelatedRegulatory Agency: Food and Drug Administration Essay1617 Words   |  7 PagesAgency: Food and Drug Administration Victoria Steele University of Phoenix Regulatory Agency: Food and Drug Administration The regulation of all areas of health care in The United States falls to The United States Department of Health and Human. One such area is the regulation on medications dispensed within the United States. The section of The United States Department of Health and Human Services responsible for regulation on medications is the Food and Drug Administration (FDA). WhereasRead MoreDifferent Applications For Small And Large Molecules1623 Words   |  7 Pagesand BLA. Why are there different applications for small and large molecules? A small molecule drug approval required a New Drug Application (NDA) because it covered under Federal Food Drug and cosmetic Act Section 505 while large molecule drug required a Biologics License Application (BLA) because it covered under Public Health Service Act Section 351. Compared with conventional small-molecule drugs, products derived from a biological source are structurally complex, large molecules and involvedRead MoreOrphan Drug Market Development And Manufacturing Of Products1622 Words   |  7 PagesOrphan drug which is a drug or biologic that treats a patient population of less than 200,000 within the United States. There is an entire segment of the pharmaceutical industry comprised of companies that develop and manufacture treatments for rare diseases. The Orphan Drug market has a projected Worldwide 2020 sales forecast $178bn with a compound annual growth rate (CAGR) of 11.7% per year1. The projected growth of the Orphan Drug market is nearly double that of the prescription drug marketRead MoreMarketing Analysis : Health Marketing Communications Essay1724 Words   |  7 Pagesopportunities for brands to penetrate into this market segment. However, brands have to carefully consider the credibility of marketing tools when approaching h ealth-conscious consumers since they have been growing up among information rich society. At the same time, they are familiar with traditional marketing and sales tactics. Therefore, they tend to have an open mind to initiative marketing and authentic contents rather than direct advertising. Also, it has been noted that visual contents distributed throughRead MoreStarbucks Case Study Essay1357 Words   |  6 Pageshave upgraded their coffee menus trying to mimic their style. Also coffee-houses/shops are opening who have adopted the idea of community and become just as popular and profitable. The company realized it reached a plateau and needed to develop new marketing and strategies to be competitive, retain, and gain customers. In order to remain competitive companies must stay innovative and reinvent their brand according to changes in society. A company that focuses on one advantage can limit their profitRead MorePhase Iv Of The Phase II And Phase IIi1443 Words   |  6 Pages the safety of a drug or device is a priority and this initial testing phase can take several months to complete and generally includes 20 to 100 paid healthy volunteers in study. The design of the study is to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. The investigation of a side effects also observed by an increasing the drug doses. Not all drugs are passing during this phase, but nearly 70% of experimental drugs pass during thisRead MoreEthical Issues Associated With Marketing And Advertising2384 Words   |  10 Pagessociety in general. Ethical issues associated with Marketing and Advertising: Ethical issues in marketing arise from conflicts of interest among parties doing business with each other. Ethical marketing efforts and decisions should meet the expectations of the various players in the marketing effort (Halbert Ingulli, 2012). Each party has its own expectation on how the business relationship is supposed to be. Advertisements are the most common marketing methods used by businesses. Ads last longer thanRead MoreThe Food And Drug Administration1834 Words   |  8 PagesThe Food and Drug Administration (FDA) is responsible for protecting and promoting  public health  through regulating pharmaceutical drugs, biologics and medical device in context to granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, post-marketing surveillance of the medical product, etc. The Pharmaceutical companies seek for FDA approval for a new drug to be marketed through a lon g process. This process starts with applying an application knownRead MoreThe Effects Of Distributing Thalidomide On The Late 1950s1481 Words   |  6 PagesA little white pill, sold as an over-the-counter drug, lined the shelves of pharmacies across the globe. Originating from the German drug company, Chemie Grà ¼tinethal, this pill was advertised to a highly receptive international market and was a success in 1959. Several years later, physicians began to form a link between phocomelia, a birth deformity, and pregnant woman who ingested the German-created drug. That little white pill is known as Thalidomide. Staying in the market for almost six yearsRead MorePharmaCare essay3748 Words   |  15 Pagespharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continu e to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical