The FDA is the regulatory agency in the United States that oversees the approval process for drugs, biologics, and medical devices. Which need to be submitted to the FDA before starting a clinical trial with an unapproved drug?

For a drug or medical device to receive FDA approval, the manufacturer must prove 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 demonstrate the benefits of the medication or device to determine the condition outweigh the risks that the patient may run when using the product.

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

Preparing a medicine: A company manufactures a new medicine and requests FDA approval for the seller in the United States.

Animal testing: Before assessing the drug in people, the company should test the new medication in animals to see if there is a likelihood of causing serious harm (for example, toxicity).

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), you can start clinical trials with people. 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 labeling: The FDA reviews the labeling or labeling to make sure the communication of correct information and adequately 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-company monitoring: Once the FDA approves the medication, it requires companies after FDA safety inspections regularly.

True

Explanation:

for any unapproved drug to be used for human clinical studies, the physician who developed the drug must first submit an Investigational New Drug (IND) application to the FDA.