Earlier, companies could make claims about a product without proof that it was safe. This made consumers extremely vulnerable. Currently, new products must go through the FDA approval process before they are available to the public. The US Food and Drug Administration examines, evaluates and approves a wide range of products for medical use, including drugs, medical devices, foods, cosmetics and many other health-related products.
What is the process for approval?
For a drug 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 drug or medical device, research studies and tests must show that the benefits of the drug or device for a given condition outweigh the risks. The following is a brief description of the steps required to achieve FDA approval –
- Making a drug – A company makes a new drug and requests FDA approval to sell it in the United States.
- Animal testing – Before testing the drug in people, the company must test the new drug in animals.
- IND (Investigational New Drug) – The Company submits an Investigation New Drug application to the FDA based on initial results of animal testing.
- Clinical Trials – After the FDA reviews and approves the IND Application, clinical trials can begin with people. There are 4 phases to clinical trials.
- New Drug Application – Once the drug manufacturer provides evidence that it is safe and effective; the company can submit a New Drug Application. The FDA reviews the application and makes the decision to approve or not approve the drug. It is highly recommended to hire professional NDA consulting services to prevent any unforeseen events.
- Drug Labeling – The FDA reviews labeling or labeling to ensure that it communicates correct and appropriate information to healthcare professionals and their consumers.
- Facility Inspection – This part is very important, as FDA can anytime make a visit at your facility where the drug is/will be manufactured.
- Drug approval – FDA approves the NDA application and sends a response letter.
- Post-marketing monitoring – Once the FDA approves the drug, it requires companies to undergo regular FDA safety inspections.
Why is the FDA approval process important?
FDA approval is important because it validates the need to do research 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 drug interactions. Always consult with an expert online.
