Propriety Research Paper

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

The 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 long process. This process starts with applying 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 drug is safe effective.

Drugs that a clinician or researcher may view as a single medication are distinguished by a multitude of various codes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2965522/ For example, if a researcher wanted to compare the effect of taking 81 mg/1 aspirin, they would not be able to easily find the same drug produced by two manufactures solely by looking at the NDC codes. If they were to look at 81 mg/1 coated tablet aspirin for the distributors Chain Drug Consortium and Preferred Pharmaceuticals, Inc Aspirin, the respective NDC numbers are 68016-642-12 and 68788-0186-2. When looking at the patterns in the numbers, there is no simple way to deduce that these drugs are the same. http://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm To combat this, the NIH combines the NDC codes with their own database, RxNorm, which provides normalized names for many generic and branded drugs. This database was fortified from a knowledgebase from the healthcare industry company First Databank.

In the past, no regulations existed to protect the public from dangerous drugs. To obtain permission to market a drug, the manufacturer must satisfy the Food and Drug Administration that the drug is both safe and effective. FDA approval requires clinical trials to determine both safety and efficacy and can take a decade or more.

Drug development is the process of bringing a new pharmaceutical drug to the market. The main goal of drug development is to produce safe and efficacious therapeutic products for the promotion of health, and the prevention, cure and treatment of disease.

During this phase the drug is considered and the talk of different dosage, patients and longevity of use is looked over. After phase three the drug is written up again in as a new drug application and is filed to the FDA in which they have 60 days to review and submit in order for this drug to get out. Following there are different steps of approval determining the severity of need for the drug and its underlying benefits. In most cases it will take some time and scrutinizing of the FDA’s review team before the drug can be released, but under certain circumstances drugs may be approved for release without the sponsors showing its safety and true effectiveness. This process is called “accelerated approval” in which if there are very few cures for a certain disease or none at all then a drug can be approved for use, it will be reviewed and possibly withdrawn but just the act of allowing such a thing to occur yet again should not sit well with most. The most recent example of this would be studies shown of Chronic Myeloid Leukemia in which they released a drug that barely passed phase two. They call it in these dire circumstances a “surrogate endpoint” almost as if the patient is already dying so the outcome, good or bad is ok as long as they see the effectiveness of this drug. In concluding the process of review it appears that there is a great system of checks and balances and a great deal of care put in to the

The regulatory body in USA is the FDA, in the European Union the EMA, the European Commission and the national authorities of the EU member states and in the Canada the Health Canada handle the drug review processes. Each agency has their own distinctive approaches to approve drugs biologics and medical devices. The globalization of the pharmaceutical industry, harmonising the drug regulatory approval process of the US FDA and EU EMA, and Health Canada is essential to speed up the progress of new treatments. The main goal of all agencies is to put a drug in the market in safe, efficient and faster. We will examine here the agencies’ approval process time frame and other drug approval pathways.

This lead Americans to ask who is supposed to be regulating these drugs and why were they not doing their job. The Food and Drug Administration (FDA) is responsible for making sure that drugs are safe and effective before they are introduced to the public. However, once the drugs are approved and dispensed, the FDA’s job is still not done. After a drug is released to the public, it is the job of the FDA to monitor it and ensure that the drug is being used in the way it was meant to be used when created, but there are many loopholes the pharmaceutical field has taken advantage of. For instance, the FDA created a program called RiskMAPs which was designed to minimize the risks of a drug while still distributing the benefits of the drug to the public and is submitted to the FDA during the approval process of the drug. The loophole here is that RiskMAPs is optional and the FDA can only recommend that RiskMAPs is used. Another loophole is that the FDA is not exactly allowed to monitor how the drugs are advertised to consumers (Collins). Essentially, the FDA is totipotent in regulations before the drug is released to the public, but once it is released, the regulatory abilities of the FDA are minimal. The FDA is the main source of regulation when it comes to drugs, but individual

IV. Chemistry Review: Each review committee has an chemistry review department for reviewing the chemistry of the drug and the agenda of this chemistry department is to address issues related to drug identity, manufacturing control, and analysis. The reviewing committee ensures that the

In order for a pharmaceutical company to gain FDA approval for a drug, the company

Ethical research is crucial in protecting the civil rights of participants. Ethical standards also ensure sound methodology in research studies. This paper will analyze the different standards of ethical research.

of the drug approval process and involves clinical pharmacology, an area of medicine devoted to the evaluation

The pharmaceutical industry includes companies that research, develop, market or distribute generic and branded drugs. The industry expanded during the 1980’s and drugs to treat heart disease and AIDS were prominent. Consumer demand for nutritional supplements and alternative medicine increased during the 1990’s with the Internet facilitating direct purchases of drugs. Advertising for direct consumption of pharmaceutical drugs became more prominent; pharmaceutical companies were criticized for over medicating personality or social problems.

The United States have to go through a broad review in order to get the approval process by the Unites States Food and Drug Administration before any drugs can be prescribed to any of it patients. By the end of the year 2016, according to the 3.2 billion drugs were ordered from many physician practice for there patients (CDC, 2016). Many of these good and some are harmful drugs have bombarded numerous of pill bottles. Currently, the drugs supposed to go through a process of development, and next approval before being introduce/marketing to patients as well as consumers. However, having a clear outlook at the procedures that should be required to market drugs from the beginning to the end. Also, topics about the testing in

As mentioned in class, as well as in the required Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008).