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

I look up from my phone after the clock turns from 11:59 pm to 12:00 am and gaze upon Honey Pot Lake as it mirrors the pink and gold clouds illuminated by the setting sun’s rays as they bend over earth's curvature. I take in the beauty of the sunset and await the soon to come sunrise. As i, for the last time, experience the beauty of the pristine nature that bethel alaska has to offer, turn my head towards my adjacent friend and proclaim in a gloomy yet glad tone, “I never want to leave this place.” My experiences in bethel alaska from my two school immersion trips truly formed who I am today.

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

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).

12. The FDA would not let unsafe replications of drugs onto the market, prescription or over the counter medications

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

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

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.

1-A new investigational new drug application (IND). Expanded access with the new investigational new drug application (IND) involves submitting a new IND or there is an existing IND in effect for the drug, but the sponsor of the existing IND declines to be the sponsor of the access use through a licensed physician (21 CFR 312.310). There is a review period of 30 days, and during this period the treatment cannot proceed (21 CFR 312.40 and 312.305(d)(1)). However, the FDA could notify the sponsor to begin the treatment process earlier. The investigator should have an agreement with the sponsor to supply the investigational product to the patient and the health care professional for treatment.[2]

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;

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.

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.

According to the globalist.com, the U.S. Office of Management and Budget states that the person reading this right now has a life worth roughly seven to eight million dollars. Other agencies, such as the Environmental Protection Agency, have the number set at 9.1 million. It’s interesting to think on this number considering that some people will never come close to making or seeing this amount of money. Although, at the same time, studies have conducted that you as a human being are worth that much. So if we are worth so much, for example nine million, then an estimated 13,032,000,000 dollars in human lives have been wasted since 1976. This is the year that the death penalty was reinstated. This was a wrong move on the government’s part