Risk Evaluation and Mitigation Strategies (REMS) are the newest tool of the FDA to help manage and ensure safe drug use. REMS are a particularly important issue for oncology, because a disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders.

It is better to require oncologist members of reimbursement committees to ponder trade-offs than to allow those trade-offs to languish in obscurity.

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics, which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer.

While controversy has raged over the Food and Drug Administration's (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA's role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...

While controversy has raged over the Food and Drug Administration’s (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA’s role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...

While biopharmaceutical companies may be thought of as mission oriented, they are almost certainly the poster children for adaptation. They need to focus on finding the most pressing relevant issues to help their patients.