In This Paper, I Am Going To Discuss About The Premarket

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.

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 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.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses

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).

There are two modern Food and Drug Administration (FDA) actions that are important to review and their impact today; the Prescription Drug User Fee Act passed in 1992, and the Food and Drug Administration Modernization Act passed in 1997. Under the Prescription Drug User Fee Act, the FDA was authorized to “collect fees from pharmaceutical companies to review their drug applications” (Shi, 2016). This fee collection process shortens the time for new drug approvals and allows the FDA to make the drugs available for use much sooner. Congress went a step further by with the Food and Drug Administration Modernization Act that provides for

Before getting marketing approval for any drug in United States it has to pass through FDA review process. Under prescription Drug User Act (PDUFA) came in effect in 1992, FDA has set up specific goals to improve drug review process time and created two tiered system of review times. The standard review and The Priority Review.

Animal Pharmacology and Toxicology preclinical data is necessary to assess whether the drug is safe for initial testing in human. Manufacturing information that consists of the make up, the manufacturer itself, stability, and controls used to manufacture the drug product. And clinical protocols and investigator information gives detailed protocols for clinical studies to assess whether the first phase trials will expose patients to unnecessary risks and obtaining informed consent.

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 current regulations governed by the FDA are very strict and should remain that way because the base of these regulations are underlined by various tragedies which we don’t want to be repeated. For instance, the thalidomide incident in which many children were born with Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as a remedy for sleeplessness was later found to have off-label effects such as mitigation of morning sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However, in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris-Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical trials, new drug development and manufacturing of drugs, biologics and medical devices.

In order for biotechnology and pharmaceutical companies to market their biologics and drugs, companies must receive approval from their respective regulatory authority. The three global leaders in the pharmaceutical industry US, EU, and Japan all have their own regulatory authorities. Each have their advantages and disadvantages and as a regulatory representative. Though there is a push to harmonize regulatory requirements at a global scale for the past 20 years development and approval of global guidelines has had drawbacks in approving drugs at a globally. The high regulatory uncertainty is considered as a major barrier for efficient development of safe and effective biological therapies, hence deterring entry for large multinational pharmaceutical companies to develop innovative biological products at a global level.1

The present review describes the importance of validation in pharmaceutical industry, its requirement for approval of new drug application by the various regulatory agencies. Furthermore it highlights the current guidance on process validation by USFDA, EMA.

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