Can the FDA withdraw a New Drug Application (NDA) based on negative reports?

The ability of the FDA to withdraw a New Drug Application (NDA) based on negative reports is indeed true. The FDA has the authority to assess the safety and efficacy of new drugs throughout the approval process and can take action if new data or reports suggest that the drug may pose undue risks to patients.

Negative reports can come from various sources, including post-marketing surveillance, adverse event reports, or findings from ongoing clinical trials. If the FDA determines that the risks outweigh the benefits of the drug, or if there is new information that raises safety concerns, it has the power to withdraw the NDA, ensuring that only safe and effective medications are available to the public.

In terms of the other options, the FDA's decision is not limited to reports from clinical trials or tied to the necessity of a market recall. The focus is on the overall assessment of the drug based on all available information, reinforcing the regulatory agency’s commitment to public safety.