FDA HUMAN DRUG REVIEW AND APPROVAL BASICS MODULE

FAQs

1. European legislation makes a distinction between compassionate use and off-label use. Are they the same in the United States?
   1. No. Compassionate use is commonly used to describe some of the ways of making unapproved products available to patients. Off-label use applies to a product that is marketed and approved for one treatment but a prescriber chooses to use it to treat a different condition.
2. When FDA and a company seeking product approval meet, are the application reviewers present?
   1. FDA staff that review IND applications participate in the meetings with industry. The reviewers are the same throughout the IND and NDA/BLA process. Since the process can take a long time before the NDA and relevant data are sent to FDA, reviewers are familiar with the company, people in the company and the compound.
3. Is FDA liable for medical product decisions?
   1. While FDA is held to a high scientific standard by the courts, the Agency is not liable. The company that sponsors the application is the liable party.