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The COVID-19 situation has kept the world wide awake and cautious of every step towards safety and health. Researchers and clinicians are constantly delivering their services towards making drugs and vaccines against this viral disease but the commercialization of these drugs have to follow a strict path of stringent regulations. I am sure most of you have heard about the FDA in relation to COVID-19 therapy or drug approval scenario but what is FDA and how can drug companies go ahead for gaining FDA approval? Let us discuss.

What is FDA?

The Food and Drug Administration (FDA) is a federal agency of the USA which is responsible for promoting and protecting public health. The FDA controls and supervises biopharmaceuticals, medical therapies, kits, drugs and food supplements, just to name a few services. According to a study by MIT, around 14% of clinical trial drugs gain FDA approval as the US federal agency sees this as a stringent step towards public safety. Most other drugs which do not gain approval for commercialization, are either halted by the company or are taken up for repurposing. Around the year, several companies pitch their drugs or medical services to FDA for approval and it is the same thing for COVID-19 situation. In the following section, we further brief you on how the companies try to ensure proper FDA approval procedure.

Major Steps to FDA Approval for COVID-19 Therapy?

Organizing Paperwork

Check the FDA website to ensure that all the required forms are completed and submitted. An important mention should be made of the 1572 form which is very crucial for investigational new drug (IND) submission (COVID-19 therapy in this case). The 1572 form ensures that companies or research organizations do not have any conflict of interest or bias. It further ensures that the FDA code of Federal Regulation is followed for clinical trials and the researchers have necessary experience and designation to conduct the experiments ethically.

Presenting Evidence

Upon the completion of clinical trial, the results are reviewed by the board members of FDA and an open discussion meet is organized where the business companies present evidence on how their proposed drug is ethically sound and more effective over other significantly effective drug candidates. The goal is not to determine the safety or biocompatibility but to prove that if approved for commercialization, this will enhance health in a much more improved way than other available drugs. This step is crucial as many companies lack data on the efficacy and advantages of their drug candidate over other drugs or already commercialized treatment measures. A frame of reference for critical comparison is required by the companies to help FDA evaluation of the improvement proportion and the nature of it.

Keeping Records

Every stage of a new COVID-19 drug’s development and testing should be thoroughly recorded. From pre-clinical data in vitro to human clinical trial results, every step of development should be assessed for loopholes. Companies should also prove that the drug has been tested on adequate no. of subjects before coming to a conclusion on its benefits. At times, due to absence of proper reports, adverse effects are not mentioned and that can ultimately create a bias in the approval scenario. It is very critical to prove that the benefits of the new drug outweigh side effects (if any) and are acceptable as a commercial drug product. For example, if a COVID-19 drug elicits mild symptoms of vomiting or nausea but increases the life expectancy manifold, that drug is considered viable and good. This comes under risk evaluation and mitigation strategies (REMS).

Final Consideration

Last but not the least, a count of minimum 80% subjects should show improvement in clinical trials for a drug to be approved. This, along with proper assessment of drug development reports, cohort evaluation, side-effect records, etc. are the pillars of FDA approval for a new drug (e.g., COVID-19 drug).

In this whole procedure, there is an involvement of the company’s in-house expert biomedical researchers, biostatisticians, ethical committee, and clinical trial committee. But companies which do not possess much in-house facilities, look forward to collaborate with other organizations and institutes. Lastly, FDA can audit the company facility where the drug is being developed and tested, to ensure GCP guidelines.

Applying for FDA approval can be difficult and thus there are many agencies who provide consulting services on FDA procedures in order to run a smooth chain of events. For recent information on COVID-19 drugs under FDA regulations, visit https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs 

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