Postmarketing Requirements and Commitments - U.S.
When the U.S. Food and Drug Administration grants marketing approval to a new drug or biologic, it may condition that approval on the sponsor’s commitment to conduct certain future studies and clinical trials, in order to generate additional useful data on the safety, efficacy or optimal use of the medicine. Some of these studies and clinical trials may be required. This website provides information on Bristol-Myers Squibb’s U.S. postmarketing requirements and commitments. These studies build on the data that was submitted for approval.
The data available on this site includes:
- Product (generic and trade name)
- Description of the Requirement or Commitment
- Projected Completion Date
- Study Status
- Relevant or explanatory notes, if any
Differences may be noted between the status of a requirement or commitment reported here compared to the status as reported on the FDA website. This is usually a result of the fact that the FDA requires time to review the data, as well as update its website.
The Bristol-Myers Squibb website 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 requirement or commitment is fulfilled or they release the company from its commitment, it will be removed from the website.
U.S. Postmarketing Requirement and Commitment Studies
Selected Product: ABATACEPT
Description of Commitment
Protocol IM101045A, a pharmacoepidemiology study to assess the short term (2 years) and potential long term (4 years) risk of hospitalization due to infection (all hospitalized infections, hospitalized pneumonia, and all opportunistic infections) among patients with RA treated with Abatacept in comparison to other DMARDs within a large cohort of individuals with commercial health insurance. This study will also characterize patients receiving Abatacept and monitor any off-label use.
Description of Commitment
Protocol IM101045B, proposed as an observational prospective pharmacoepidemiology cohort study to assess the short and long-term risk of malignancies and infection in patients with RA treated with Abatacept in comparison to other DMARDs within an existing registry containing patients with rheumatoid arthritis. Follow-up will be for at least 5 years after the last patient is enrolled.