Cdr Case Study

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

Intellectual Property: Johnson & Johnson have the rights to many products including: JOHNSON’S® BEBE® PENATEN® PRIM’AGE® JOHNSON’S® BEDTIME™ JOHNSON’S® SOOTHING NATURALS™ DESITIN® NATUSAN® NEUTROGENA® SHOWER TO SHOWER®PIZ BUIN® AVEENO® LUBRIDERM®AMBI® SKINCARE VENDOME® CLEAN & CLEAR® PURPOSE® ROC® ROGAINE® BAND-AID® Brand Adhesive Bandages BENGAY® CALADRYL® PURELL® NEOSPORIN® CORTAID® SAVLON® COMPEED® TUCKS® DAKTARIN® LISTERINE® EFFERDENT® LISTERINE® WHITENING REMBRANDT® REACH® STAYFREE® MONISTAT® CAREFREE® e.p.t.® K-Y® O.B.® TYLENOL® SUDAFED® ROLAIDS® DOLORMIN® MOTRIN® MOTILIUM® MYLANTA® ZYRTEC® and ZYRTEC-D®12-HOUR® BENADRYL® IMODIUM® PEPCID® NICORETTE® SPLENDA® LACTAID® BENECOL® SUN CRYSTALS™ VIACTIV® VISINE® ACUVUE® CONCERTA® REMINYL® /RAZADYNE® TOPAMAX® HALDOL® RISPERDAL® INVEGA® RISPERDAL® CONSTA® DORIBAX™ PREZISTA™ INTELENCE™ RETIN-A MICRO® LEVAQUIN®ORTHOCLONE OKT-3® REMICADE® DURAGESIC® AXERT® ORTHOVISC® ULTRAM® ER Tylenol® with Codeine DITROPAN XL® TERAZOL®ORTHO TRI-CYCLEN®ELMIRON® ORTHO-CYCLEN® ORTHO TRI-CYCLEN® LO ORTHO EVRA® ORTHO-NOVUM®RhoGAM® DACOGEN® PROCRIT® DOXIL® VELCADE® LEUSTATIN® ACIPHEX®/PARIET® REGRANEX® NATRECOR® REOPRO®. They also have the patents and copyrights to a wide array of drugs and medical equipment.

FDA’s Center for Drug Evaluation and Research (CDER) works to ensure that the drugs release in the market are safe to be used by general public. They evaluate prescription as well as non-prescription drugs for their safety effectiveness and quality. They review the drug before being marketed to improve overall health

“a paperless, digital and computerized system of maintaining patient data, designed to increase the efficiency and reduce documentation errors by streamlining the process.”(Santiago, n.d., para. 1)

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

A powerful IT infrastructure is necessary to advance healthcare quality. Among countless other advantages, an effective IT infrastructure generates accurate and accessible performance data, allowing monitoring of results. However, Hill absorbed the cost to physicians which encouraged their physicians to adapt to the new system. Similarly, they made sure the system was user friendly which lessened frustration and resistance.

Health information technology or HIT is a huge part of the dashing changes in how medications are prescribed, dispensed, and administered by using technologies electronic devices to share and manage patient information, instead of doing it the old fashion way which was over the phone, having all patients’ records and files on paper, and using the old fax method. Everything is computerized, from managing the

In observation, (Fahnestock, McComb, & Deshmukh, 2013) stated "Information technologies are transforming the way healthcare is delivered. Innovations such as computer-based patient records, hospital information systems, computer-based decision support tools, community health information networks and new ways of distributing health information.” (p.3.2). In the sector of delivering healthcare using technology, has made it easier for healthcare professionals to access medical records, digitization of prescriptions and view test results. With the use of high-performance devices being used in the hospital, helps to make the jobs of healthcare professionals a little easier. As well as relieve anxiety from anxious patients that may be awaiting lab results to come back. Therefore, IT devices and services has been and continues to be a tremendous help and game changer for the healthcare system. However, there is still a lot of work to be done to help shape and reform the healthcare

Transmitting prescriptions by digital mediums has organized and facilitated the operation of clinical procedures, and improved the commitment and satisfaction of patients. In addition, linking physician and pharmacy systems has minimized paperwork and the associated mistakes that may occur from relying on handwritten notes. This change has produced time and cost savings for all parties involved. (Bigler L.,

There a couple of strategies that I could employ in order to succeed in UNE CDM’s externship requirement. An important factor in attaining success is to set goals. In order to set these goals, I would need take a moment to observe the area and get to know some of the people in the that way I can get a better idea of what the area is in need for. Additionally, I will take the time to educate my patients. Educating them on what exactly is going on and how to prevent it is the most valuable care that I can give a patient. Most importantly I will show them kindness and compassion. People don’t care how much you know, until the know how much you care. No matter where I go I will always treat my patients with respect. I want them to know that I am

The U.S. Food and Drug Administration (FDA) is "responsible for protecting the public health by regulating human and animal drugs, biologics (e.g. vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation."

In order to ensure successful integration, the organization must ensure that the key players, mainly the physicians, are informed of the benefits to the individual physician, the health care organization, and health care as a whole

|After such a fantastic run the industry is facing new challenges, raising questions about its future. For us to understand the current state of |