Application Via The 505 ( B ) 2 Mechanism

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

The time frame and cost to release a drug for sale into the United States market is enormous. After nearly 20 years and about one billion dollars spent, a drug manufacture can begin to market its product to consumers (Philipson & Sun, 2008). The reason behind these huge numbers is the drug approval process mandated by the Food and Drug Administration. Understanding the testing process will explain the long time frame and huge costs associated with drug approval.

The scope of the drug development process is defined to prepare the audience to understand the role of regulatory affairs professionals. Responsibilities and roles of regulatory affair’s professional are explained and described in the presentation. However, the functional role of a regulatory affair professional in cross-functional area has not been included. Addressing the Importance of communication skills and experience can provide added incentive to the reader for personality or characteristic of the profession. The presentation is direct to the point and delivers basic understanding of the role to the audience. However, it can be expanded to include additional details such as educational prerequisite and job characters to describe the professional

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

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.

Under this act only treatments for unmet medical needs would be eligible. Some helped to improve outcomes and reduce risk more often than those approved by the FDA. All of these drugs could not already be on the market or they would not be eligible. To do this it is required of sponsors to give up all other IP protections for indications protected under dormant therapy exclusivity (Usdin).

Implementation of Good Clinical Practices under part 21 CFR 50 (protection of human subjects) which includes the document ICFs, under part 21 CFR 54 (Financial Disclosure), under part 21 CFR 56 (IRBs) and Under part 21 CFR 312 (Investigational New Drug Application) should be provided. [7] These documents will help us to ensure whether the study was performed with the willingness of subjects ' to participate and the subjects were aware of the risks and benefits to the exposure to the drug. And also the sponsor and investigator both had signed the financial disclosure forms.

The healthcare rofessional explain the process of obtaining the investigational product to the patient is of prime importance especially when the patient has exhausted all the available medications and therapies. During the clinical trials, Andrea or any patient cannot obtain the drug until the drug becomes approved or the patient is eligible for the study according to the protocol. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The investigational new drug (IND) is the means through which the sponsor technically obtains this exemption from the FDA. The IND is not an application for marketing approval. Rather, it is a

The classification is vital in establishing the future plan of the product as well as the regulations needed in order to receive FDA approval for the product. This will be done by looking over the Food and Drug Administration website. The product claim must be established in order to establish a concise focus of the product. There will be repetitive and tedious edits in order to establish a thorough statement. The regulatory plan and healthcare developmental plan are implemented in order to create a detailed and complete outline of every step needed to be taken in order to gain approval of the product. The detailed process can be found in the methodology steps but it includes working with the federal

Even though I think conducting clinical trials in emerging economies is beneficial to the firm, Novo Nordisk should still follow below guidelines for this major decision to protect its own reputation and serve the best interest for every stakeholder:

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

announced its intention to submit an application to the U.S. Food and Drug Administration (FDA)

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).