FDA Approval Process

The FDA approval process is the process a new drug must undergo by the Food and Drug Administration to be determined safe and effective.

Case Study

FDA Marketing Compliance Expert

An FDA marketing compliance expert was needed for a case involving allegations of pharmaceutical product mislabeling and failure to meet FDA regulations and requirements.

Case Study

Pharmaceutical Development Expert with FDA Approval Experience

A pharmaceutical development expert was sought for a misappropriation of trade secrets claim against the Food and Drug Administration.

Case Study

FDA Submission Expert in Clinical Trials

A FDA submission process expert was requested to evaluate the clinical trial of a transdermal application of an anti-inflammatory drug.