...One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific...
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...Dfssdsdfa Dfas Dfas Dfs Afd Sf Sdafsd Afsd Afsd Afsd Afsda Sd F Se Fsrfse Rtrlfk kk k rk rk rer ll l l rlel l osos oll lrwl Fkskfk s Kfskfk Kkfskfs S S kfkkrsoroes Fklslala Kedkeak Askfkosao Keklalelaeo Eoaoe Dosaa e supply chain and headed Zara in Scandinavia. “Martinez will use his experience in supply-chain management to improve the delivery time-lag at Esprit,” said Paul Cheng, vice chairman of Esprit. “We used to launch new products every season, but now we may need to move quicker.” In June, Inditex reported a 30 percent gain in first- quarter profit, beating analyst estimates. The retailer’s success is reflected in the rising fortune of Amancio Ortega, its septuagenarian founder who this week bumped Warren Buffett from his perch as the world’s third-richest person. The 76-year- old Spanish tycoon’s fortune climbed by $1.6 billion to $46.6 billion on Aug. 6, according to theBloomberg Billionaires Index, as Inditex stock rose to a record. Fashion Pioneer Esprit’s revenue growth slowed to 0.1 percent in the year ended June, from 26 percent in 2008, according to data compiled by Bloomberg. Inditex’s sales increased 10 percent in the year ended January, topping H&M’s 1.4 percent gain for the year to November and Gap’s 0.8 percent drop in the year ended January. Zara, the main Inditex brand, was a pioneer of fast-fashion and has sought to reproduce designer looks at affordable price. “It is certainly a blow to Inditex to lose one...
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...Agency for pharmaceuticals is a complex and often lengthy one. Done out of necessity to ensure the products being introduced into the growing healthcare field are overall safe and effective for utilization by patients. While the process is far from perfect it still a staple in introducing innovative and breakthrough drugs into healthcare fields across the board. This paper will discuss the process encountered to get pharmaceuticals approved for manufacture and distribution to physicians and patients. Food and Drug Agency’s Drug Approval Process “For healthcare technology, the most important regulatory approval comes from the federal Food and Drug Administration (FDA)” (Williams & Torrens, 2008, pg.28). This agency approves all drugs and pharmaceuticals, medical devices, and some medical equipment. The FDA also controls access to drugs by deciding whether a certain drug will be available by prescription only or as an over-the-counter purchase (Shi & Singh, 2013, pg.115). The most well-known regulatory review of medical technology is that conducted on pharmaceutical products and to some medical devices that are subjected to detailed preliminary approvals, clinical trials, and post-approval surveillance policies. Before a drug can begin (first phase) clinical testing, the sponsor of the drug must evaluate the product’s safety and biological activity via in vitro and in vivo lab (animal) testing. If product appears to have important biological activity and may be useful...
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...foods, will factor into my eating habits for myself and my family. This will affect me directly as it could lead to a change in the foods I choose to cook and eat. 2. Describe the proposal/change. The proposal will allow the FDA to collect information from a study about the relationship between selenium and the risk of various cancers. The proposal will also dig deeper into scientific evidence of whether health claims are ‘complete, truthful and not misleading’. The proposal will enforce companies to enable the public to comprehend the information provided and to understand the relative significance of such information in the context of a total daily diet. 3. Write the public comment which you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points) My comment is that I encourage this new scientific study to be done so that the public is not misled on whether or not Selenium (trace mineral that is essential to good health but required only in small amounts) is beneficial to the body or not. There have been several claims that conclude that the mineral reduces the risk of certain cancers, but the FDA has ruled that these claims are very limited and not conclusive. For this reason, more research should be conducted. This new proposal will lead to the truth behind the alleged claims. I wish to have them carry-out this new...
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...this chain of event FDA is also being dragged since FDA did not pass the Original Tracking Bar rule. A lot of people are saying that FDA is responsible for these, although it is clear that FDA does not have any liability towards the these victims. Robins and Robins has caused this problem and they were one of the most active members who opposed this regulation and even bribed companies to be against it. they went ahead and they convinced the addicts to support them. Robins and Robins lobbied against this rule and got the rule stopped during the public comments period. Even after Robins and Robins was aware of the problem caused by their medicine they did not make a justified effort to recall their product. It could never be a 100% recall since there is no tracking methodology that can be used. As far as the role played by FDA is concerned they did the right thing in stopping this bar code rule. They could not pass it without public’s consent and majority of them had voted against it. They thought it would violate their privacy rights. And also doing this would have increased the price of the medicine which was a big concern. As it is hard for people to afford medication as is and with this the price increase would have been tremendous. It was not only Robins and robins that lobbied against it but there were certain public interest groups involved as well. The death and illness have been caused because of the negligence of Robins and Robins and not the FDA. In response to the...
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...U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This project explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs. Patients, more than pharmaceutical firms, shape the political costs to the FDA of delaying drug approval. Consider two hypothetical consumers, one a pharmaceutical consumer (“patient”) who wishes to try a new drug for some ailment, the other a vitamin consumer who wishes to take zinc supplements to ward off a cold or flu. There are few institutional restrictions upon the consumption decisions of the vitamin consumer, at least in the United States. She is free to purchase vitamin products over the counter, and the vitamin manufacturer is free to sell them without prior authorization or licensing. Not so with pharmaceuticals. The marketplace for pharmaceuticals is one of the most highly regulated industries in the U.S. economy.1 To use any new pharmaceutical product, the patient must secure the...
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... 2. Describe the proposal/change. The Internal Revenue Service (IRS) issued proposed regulations that add excise tax on the sale of medical devices under Internal Revenue Code. The tax applies to the sale of certain medical devices by a manufacturer, producer or importer of the device. The tax is in the amount of 2.3 percent of the sale price and will apply to all devices that are sold after Dec. 31, 2012. The Treasury will be holding a public hearing on May 16, 2012, at the Internal Revenue Service in Washington, D.C., and comments on the proposed regulations and outlines of the topics to be discussed at the public hearing are due by May 7, 2012. The imposed sales tax will use the FDA Medical Device Listing for medical device categorization, and definition, such devices defined under this FDA regulatory law as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or animals, or intended to affect the structure or function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being...
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...Mohammed’s part: What does the FDA do? FDA is responsible for protecting the public health by assuring the safety and security of human and veterinary drugs, biological products, and medical devices. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines to maintain and improve their health. Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by fostering development of medical products to respond to deliberate and naturally emerging public health threats. What does the FDA regulate? The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction Drugs, including: • prescription drugs (both brand-name and generic) • non-prescription (over-the-counter) drugs • vaccines • blood and blood products • cellular and gene therapy products • tissue and tissue products The Federal Drug Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. ...
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...Food &Drug Administration (FDA) IT Security Project Plan ITEC640-9043 October 14, 2015 Table of Contents Introduction…………. …………………………………………………………………Page 3-4 Project Organization…………………….……………………………………………....Page 5-6 Statement of Need ………………………………………………………..…………….Page 7-8 Project Definition ………………………………………………………………………Page 8-10 Approach to Developing Project Plan………………………………………………….Page 11-12 References………………………………………………………………………………Page 13 Introduction Green Team Consulting Company is a team of professional project managers, who are hired to assist organizations with known network integrity issues after a cyber attack or data breach. The Greet Team is an investigative firm that specializes in a high quality, detailed analysis of the breach, development of a project mitigation plan, evaluation of any legal implications that may result in the future, and implementation strategies of new systems and workflows that will ensure future network security. Walter Harris, the Chief Operations Officer of the Food and Drug Administration or FDA, has contracted with the Green Team after a critical data breach that exposed confidential information. The data that was exposed includes but is not limited to: employee records, new pharmaceutical drug proposals, clinical trial results, and complaints filed about products the FDA regulates. The three main goals of this project will be to target the cause of the data breach, review the consequences this breach...
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...Corruption in the FDA and USDA Scott A. Weidner Cardinal Stritch University Business Ethics MGT 460 Rozine Smith February 28, 2013 Table of Contents Abstract.............................................Page 3 Authors intent (thesis statement)....................Page 4 Ethical Concerns …………………………………………………………………………………………..Page 4 The Root of the Problem…………………………………………………………………………..Page 6 Chart of Monsanto appointees……………………………………………………………..Page 6 Which Administrations are Guilty…………………………………………………..Page 8 Obama Appointees……………………………………………………………………………………………..Page 10 Damage and Effects………………………………………………………………………………………….Page 12 Recommendations………………………………………………………………………………………………..Page 13 Abstract At the heart of the issues of corruption in the FDA and USDA are the appointees to the departments. Many are former employees of Monsanto. A former director of Monsanto made the statement Monsanto should not have to vouchsafe the safety of biotech food that is the job of the FDA. The FDA says that food manufactures should be responsible for what they produce. Ironically, the FDA is controlled largely by Monsanto, and Monsanto is regulated by the United States Government, with neither side willing to take ownership of the issue. The first Monsanto appointees in the FDA were placed under the first Bush administration. In each subsequent administration more appointees were taken from Monsanto. President Obama is responsible for the largest number...
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...The Food and Drug Administration is a federal agency of the United States Department of Health & Human Services. The FDA agency controls a broad spectrum of things, ranging from medical devices, public health, drugs, to animal food and dietary supplements. The Food and Drug Administration is an agency that helps protect the public, by regulating an ever-increasing amount of things in our life, and making sure nothing harmful is let in to our food, water, and medical care. The FDA (Food and Drug Administration) is led by the Office of the Commissioner. The FDA has 22 offices/centers, or subdivisions. The offices range from Tobacco regulation, Cosmetics, to Public Safety and Food Regulation. The FDA currently has 223 field office and 13 laboratories that have been popping up over recent years, and they exist and function solely for the FDA's purposes of research, testing, approving, and clearing various products, foods, and goods....
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...Thesis: One of the biggest agencies within the U.S. Department of Health and Human Services is the Food and Drug Administration (FDA). The Office of the Commissioner and four directorates administer the core functions of the agency which are medical products and tobacco, foods and veterinary medicine, global regulatory operations and policy, and operations. While being a huge, big named agency designed to protect and provide public health; there are necessary regulations and guidelines to ensure the purpose of the agency is being met. This paper will explore the needs, stakeholders, expected outcomes, and other regulatory action and implementation of the FDA. Introduction: The Food and Drug Administration Safety and Innovation Act (FDASIA) is a regulation which was proposed by The Food and Drug Administration (FDA or Agency) to establish a list of “qualifying pathogens” that are likely to cause serious harm to public health. FDASIA utilizes the agency’s ability to protect and improve public health by giving the authority to collect user fees, promoting innovation, increasing stakeholder involvement, and enhancing the safety of the drug supply chain. Methicillin-Resistant Staphylococcus aureus (MRSA) is a “staph” germ that does not improve with the first-line antibiotics that typically cure staph infections. When this takes place, the germ is “resistant” to the antibiotic. This class of antibiotics includes penicillin, amoxicillin, oxacillin, methicillin, and others. (MRSA...
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...The Roles of the FDA in Protecting the Patient Rasmussen College Author Note This paper is being submitted on October 18, 2015, for Trang Nygyen’s PTN1009 Foundations of pharmacy practice. The FDA Roles in Protecting the Patient The current role of the FDA is to protect the public health by assuring the safety, efficacy and security of human and veternariny drugs, biological products, medical devices, our national food supply, cosmetics, and products that emit radiation.(“FDA Fundamentals, 2015”) The FDA serves as a consumer watchdog, making sure that medications are safe and effective to help improve patient’s health. All new drugs are evaluated before they can be sold to ensure they work correctly and the health benefits outweigh known risks. FDA monitors and ensures safety of drugs after approval. (“What is the FDA’s role in drug safety”, 2010-2015) Risk Evaluation and Mitigation Strategy (REMS) is used to manage a known or potential serious risk associated with a drug or biological product. REMS are required by the FDA if determined they are necessary. REMS include Medwatch, medication guide, and black labeling.(“REMS resource center, 2015”) Medwatch is an FDA safety information and adverse event reporting program. The FDA uses REMS by communicating safety information by releasing Medwatch safety alerts to subscribers and through the Medwatch partner program. www.fda.gov/medwatch/safety The FDA posts monthly label changes on the web and distributes them...
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...Research Paper FDA Approval process for Clinical Trials If you, or someone you loved, were diagnosed with a terminal disease, would you chance using a non-FDA approved medication to increase your life expectancy? Many pharmaceutical companies have the medication that could save countless lives, but the FDA clinical trials for these medicines are problematic for enrollment, and thousands of patients are often turned down. New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug...
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...Anti-Depressant Drugs and FDA Approval Anti-Depressant Drugs and FDA Approval Procedure Ashley Jensen A01054823 Pima Community College Psych 101 Abstract Antidepressant drugs fall under three main categories; MOAI’s, Tricyclic Antidepressants, and SSRI’s. Like any drug, Antidepressant drugs must get FDA approval prior to putting in on the market for society, ensuring it has no harmful effects. The Food and Drug Association has a series of trials, tests, and procedures, to ensure these drugs are safe and effective for people with severe depression. Effects of each Type of Antidepressant Drugs Anti-Depression drugs target the amygdala by directly by increasing the activity in the prefrontal cortex, therefore decreasing the reactivity in the amygdala. The amygdala has cortical and subcortical projection to other regions of the brain, such as the hippocampus, which is where we create and maintain memories. With the cortical projections increasing the level of activity for the amygdala, there is a possibility your brain will adapt and sustain a repetitive negative associations when approached with an emotion. Anti-Depression medicines target the amygdala because the amygdala is the integrated center for emotions and an emotional behavior. (DeRubeis, R. J., Siegle, G. J., & Hollon, S. D. 2008). Monoamine Oxidase Inhibitors MAOI’s were the first discovered anti-depressant medicine in the 1950’s, and they were originally used to treat symptoms of tuberculosis. Monoamine...
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