When the U.S. Food and Drug Administration grants marketing approval to a new drug or biologic, it sometimes conditions that approval on the sponsoring company’s commitment to conduct certain future studies, in order to generate additional useful data on the safety, efficacy or optimal use of the medicine. This Web site provides information on Bristol-Myers Squibb’s U.S. postmarket commitments. These studies build on the data that was submitted for approval.
The data available on this site includes:
- The product
- A description of the Commitment or Requirement
- Commitment Date
- Projected Completion Date
- Study Status
- Relevant or explanatory notes if any
Differences may be noted between the status of a commitment reported here compared to the status as reported on the FDA Web site. This is usually a result of the fact that the FDA requires time to review the data, as well as update its Web site.
The Bristol-Myers Squibb Web site focuses on clinical and other studies related to the safety, efficacy and use of the medicine. It does not list commitments related to manufacturing issues, known as “Chemistry, Manufacturing and Controls”. Also, this site lists commitments only for those products Bristol-Myers Squibb is the sponsor holding the U.S. regulatory approval for the medicine.
This site will be updated twice/year to reflect the most current information. Once the FDA determines that a commitment is fulfilled or they release the company from its commitment, it will be removed from the website.
U.S. Commitment Studies