Under what condition can the FDA revoke an already approved New Drug Application?

The FDA can revoke an already approved New Drug Application if new negative safety data emerges. This condition reflects the agency's commitment to ensuring that drugs on the market are safe and effective for public use. When evidence comes to light that demonstrates a drug may pose significant risks to patients or has harmful side effects not previously identified, the FDA has the authority to re-evaluate the drug's risk-benefit profile. If the risks are determined to outweigh the benefits, the FDA may take action by withdrawing the drug's approval to protect public health.

The integrity of drug approval continuously relies on ongoing surveillance and analysis of safety data, highlighting that the approval process is not static but rather dynamic, allowing for changes based on new scientific information. This responsiveness is vital in a healthcare landscape where patient safety is of utmost importance.