FDA Reviewing Facilities

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 FDA requires pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and analyzing thousands of reports each

The next level of concern arises with what exactly is being given out. While many pharmaceutical companies swear by their products, it is easy to forget that at the end of the day they are

Moreover, patients often have less knowledge than the prescriber does about the appropriateness of the drug, where it can be very misinforming for the consumer. Lastly, drug efficacy is a problem in all contexts. Since stakeholders are likely, less informed than manufacturers it causes both the consumer and prescriber to depend on the manufacturer for information of the effectiveness of the drug (Bennett, Quick, Velasquez, 2016).

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.

Before an investigational study on a new drug may take place, research subjects must submit informed consent and informed of all possible risks and benefits of the therapy. There are four types of phases associated with investigational studies that may occur. Beginning with the first phase, a Phase I study consist of few healthy participants who do not have the disease that the certain drug is said to treat. The purpose of this phase is to determine the optimal dosage range and the pharmacokinetics of the drug and if further testing of the drug is necessary. Vital signs, blood tests, urinary analysis, and other specific monitoring exams are performed. The next phase, Phase II, also involves a relatively small number of participants who this time have the disease that the drug is designed to treat. Participants are closely monitored to determine the effects and adverse

According to 21 CFR 312.40, an investigational new drug cannot be used on human subject before obtaining official approval from the agency. It is also mandatory that the sponsor complies with regulations mentioned in 21 CFR part 50 and 56 (Human subjects and IRB respectively). FDA would be providing a written determination 30 days after it receives an initial application from the sponsor.

This drug has some unwanted effects also and if these side effects are tackled in time, then they may bring other health complications.

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.

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.

An early consultation with FDA is valuable in the development of promising new drugs, by allowing identification of optimal strategies for efficient data collection. An initiation of early discussions with FDA in the drug development process gives the opportunity to the sponsor to consider FDA recommendations in planning nonclinical and clinical development programs.

Most people think the FDA approves all drugs on the market today, but that's not true. Some drugs are not subject to FDA approval (ex. "compounded" drugs), and others are only reviewed after they're put on the market.

To help support the Safety data and to study the potential adverse effects on the other organ systems, we would like to review the results of the following studies. This information is necessary considering the fact that the new drug is meant for long-term administration and that can contribute to long-term adverse effects.

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;

In order to test your drugs on human subjects, the company with the new drug is required to file with the FDA and submit an Investigational New Drug (IND) application. The FDA has 30 days to respond to your request. In the rare case that they do not respond, your company has the legal right to begin testing on human subjects. The FDA may issue a hold if they have any concerns regarding your drug. The FDA can choose to put your file on clinical hold in which an order is issued by the FDA to hold clinical trials on human subjects.