FDA New Drug Approval Process

The drug approval process in the United States is overseen by the Food and Drug Administration (FDA), which ensures that drugs marketed in the country are safe and effective. Here are the general steps involved:

 

1. Preclinical Testing

Before testing on humans, drugs undergo extensive laboratory and animal testing to assess their safety and potential effectiveness.

 

2. Investigational New Drug (IND) Application

If the preclinical results are promising, the drug developer submits an IND application to the FDA. This application includes data from preclinical studies and outlines the plan for human clinical trials.

 

3. Clinical Trials

Drugs undergo three phases of clinical trials:

   – Phase 1: Small-scale trials with a small number of healthy volunteers to determine safety, dosage, and potential side effects.

   – Phase 2: Trials with a larger group of patients to assess effectiveness and further evaluate safety.

   – Phase 3: Large-scale trials with an expanded patient population to confirm effectiveness, monitor side effects, and compare it to existing treatments.

 

4. New Drug Application (NDA)

If the results of the clinical trials are positive, the drug developer submits an NDA to the FDA. The NDA includes comprehensive data on the drug’s safety, effectiveness, manufacturing, and proposed labeling.

 

5. FDA Review

The FDA reviews the NDA to assess the drug’s risks and benefits. This includes evaluating the data from clinical trials and ensuring proper manufacturing standards are met.

 

6. Approval or Rejection

Based on the review, the FDA decides whether to approve or reject the drug. If approved, the drug can be marketed in the United States. Sometimes, the FDA may require additional studies or impose specific conditions on the drug’s use.

 

7. Post-Marketing Surveillance

After approval, the drug is continuously monitored for any adverse effects or other safety concerns. The FDA may take action, such as issuing warnings or recalls, if new risks emerge.

 

Read also: ANDA Approval Process in US FDA

 

Resource Person: Anshul Bansal