How The FDA Drug Approval Works- 4 Expert Tips

Posted by Greenholt Evans on October 2nd, 2019

The FDA rule on several highly customer-focused industries such as medical devices, Food and beverages. Drugs and Cosmetics. Each of these industries carry some regulations that have to be acknowledged and practiced subsequently.

What Is FDA Approval?

It means that the FDA has officially approved your product (drug or medical device) and marked it safe and effective. But complying with regulations and getting FDA approval is a major time- and resource-intensive procedure.

A recent study from the Massachusetts Institute of Technology reveals that only about 14% of all drugs in clinical trials gets approved from the FDA. This further shows that for 86% of all proposed new drugs, things go severely wrong along the process of commercialization, wasting time, energy and capital.

You can avoid the potential mistakes when applying for FDA approval, and this is what you have to do:

1. Put Paperwork in Order

Head over to the FDA website to ensure that you are submitting all the required forms and that they are completed. But when filling in the 1572 form, pay thorough attention as you can’t afford to make errors at one of the critical documents of your investigational new drug (IND) submission.

This form states that applicants don’t hold any bias or conflict of interest, that they agree to follow the FDA Code of Federal Regulations for clinical trials and that they have the required experience to conduct the study on ethical and scientific grounds.

2. Present measurable evidence

Once all required phases of a clinical trial are completed, the FDA will prepare the results and organize an open discussion -where pharmaceutical businesses all allowed to present evidence that their proposed drug is effective and have praiseworthy advantages over other drugs for the same disease. Remember, the goal is not to establish if the new drug will be safe — this has previously been identified with in vitro and in vivo studies.

It’s no surprise that most rejections happen at this stage due to the unavailability of clear data on the drug’s efficacy. That’s why it is essential to present measurable parameters on the effectiveness of the drug. For instance, it is not enough to indicate that patients’ symptoms have improved by 2%; it is also necessary to explain the improvement.

3. Maintain a thorough record

Similarly, it is imperative to accurately document every development and testing stage of a new drug’s, from accurate pre-clinical data on in vitro and animal studies, to how the initial and maximum dose was established. 

Applicants must confirm that the drug has been tested on an adequate number of subjects and also unfold whether they have reacted to the treatment effectively or not. In general, applicants should pinpoint adverse side effects that the subjects might have experienced during the trial. For example, a drug intaken by a subject to treat a terminal disease, causing frequent vomiting and migraines could get quickly approved if it is proved worthwhile to increased patients’ life expectancy. Conversely, if the same side effects were reported to treat hypertension, approval would most likely be denied, since there are already available most effective treatments in the market for that condition.

When compiling this section, be sure to go as specific as possible about what patients exactly need to do to avoid side effects.

4. Final considerations

For the drug to be approved, at least 80% of subjects in the trial must signal signs of improvement. To further make sure that this evidence is presented in a proper manner and that the sample group is adequate to provide valuable data, in that case, applicants might require the assistance of an expert statistician. It’s also important to note that FDA can audit the facility where the drug has been developed and tested, to ensure that it complies with good clinical practice (GCP) guidelines. For example, during an audit, the FDA might verify that all personnel have the necessary qualifications to complete their tasks safely.

Applying for FDA approval can be a daunting task, but having expert guidance can convert it into a smooth deal. Consult a qualified FDA application consultant today on Library Management Group and maximize your chances of having your drug approved.