The FDA's role in the drug approval process

Posted by Christina Sanchez on September 10th, 2019

This article provides information about the fda facility inspections for approving medications — the US Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) examine, evaluate and approve a wide range of products for medical use, including drugs, medical devices, foods, cosmetics and many other health-related products. In other words, FDA approval means that the FDA has decided that the benefits of the approved product outweigh its potential risks.

Before the FDA, companies that make claims about a product that it was safe or even that it worked. This made consumers extremely vulnerable. Currently, new products must undergo the FDA approval process before they are available to the public.

Why is the FDA approval process important?

FDA approval is important because it validates the need for research studies on how drugs work in children, not just adults. It also allows us to determine the appropriate dose for children, determine the best way to administer them and evaluate any interaction between medications.

How does a medication or device achieve FDA approval?

In order for a medication or medical device to receive FDA approval, the manufacturer must demonstrate to the FDA that the product is safe and effective. Although there is no risk-free medication or medical device, research studies and tests must show that the benefits of the medication or device for a certain condition outweigh the risks that the patient may take when using the product.

The following is a brief description of the steps necessary to achieve FDA approval:

• Making a medicine: A company manufactures a new drug and requests FDA approval to sell it in the United States.
• Animal testing: Before assessing the medication in people, the clinical research consultant should test the new medication in animals to see if there is a likelihood of causing serious harm.
• IND request (for research of a new drug): The Company submits a request for research of a new drug (IND) to the FDA based on the initial results of animal tests. These results should include the composition of the drug and the manufacturing and the proposed plan for the evaluation of the product in people.
• Clinical trials: After the FDA evaluates and approves the request for research into a new drug (IND), clinical trials with people can be initiated. There are 4 phases for clinical trials, beginning with small-scale trials and followed by large-scale trials. After clinical trials, the researchers present the study reports to the FDA.
• Request for a new drug (NDA): Once the drug manufacturer submits evidence that it is safe and effective; the company can submit the request for a new drug (NDA). The FDA reviews the request and makes the decision to approve or not approve the medication.
• Medication labelling: The FDA reviews the labelling to make sure that it communicates correct and appropriate information to health professionals and their consumers. 
• Facilities inspection: The FDA inspects the facilities where the medication will be manufactured.
• Medication approval: The FDA approves the NDA application (request for a new drug) and sends a response letter.
• Post-marketing monitoring: Once the FDA approves the medication, it requires companies to undergo FDA safety inspections regularly.