Case Study Of Theon Pharmaceuticals

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).

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

Should drug regulation in the United States be significantly revamped in order to encourage development of drugs targeted at chronic disease? In the United States drug regulation is taken very seriously. Congress holds the power to regulate the distribution, manufacture, and use of narcotics. Congress has the power to regulate narcotics through the Bill of Rights. “Congress may not authorize unreasonable searches and seizures or cruel and unusual punishment of narcotics violators” (Kaplan). Congress is able to see where and how drugs get transported. As of right now new medications for people with rare diseases are being created and approved through the FDA very slowly. There are a lot of regulations that they have to meet which

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.

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.

A company like Teva Pharmaceuticals is subject to all of the factors of the external environment given the nature of its business and global expansion. Pharmaceuticals is an industry where high profits can be achieved, but it is also an extremely challenging business when one considers all of the political/legal aspects involving government regulation and patents. Every country has strict regulation and testing requirements for drugs that affect companies differently depending on their position in the market. Originally, innovative pharmaceutical companies had to obtain patent protection and FDA approval but this would translate to years of protection from the generic competition. Once the

“Production … in aggregate quantities of less than 100 g per year carried out for research, medical or pharmaceutical purposes per facility. … are not subject to a declaration obligation, however, exports or imports of any quantity of Schedule 1 chemicals must be reported to

We analyzed the Indian Pharmaceutical industry on these five forces and the findings of industry competitiveness and profitability are written under the relevant competitive forces.

A standardized regulatory system should be implemented to ensure the adherence of all the set ups working with biological agents.

Moreover, one may be able to find more potential business partners in exporting to other countries. One may find a business partner that is willing to cater to and audience of Pfizer’s pharmaceutical products from another country.

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

There are advantages of starting a pharmaceutical firm in India. It has emerged from being an enzyme-producing firm to a biotech powerhouse under the guidance of Ms Kiran M. Shaw. They have a well-established pharmaceutical industry that has been growing since 1947. After the purchase of Hindustan Antibiotics Ltd. and India Drug and Pharmaceuticals Ltd. they were able to compete with the MNC’s (Multi National Corporaton) from overseas (Kalegaonkar, Locke, Lehrich, 2008, p. 2). In the beginning the pharmaceutical industry saw substantial growth. “By the beginning of the 21st century, over 20,000 pharmaceutical companies were operating in India” (Kalegaonkar, Locke, Lehrich, 2008, p. 2). “The pharmaceutical industry in India is ranked third

The finished product need to contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation and are of the purity required.