FDA Releases Draft Guidelines for Biosimilar Product Labeling

Biosimilar products are biologic pharmaceutical drugs that have similar active properties as an already-existing product. Until recently, all biologic products had to receive separate approval from the U.S. Food and Drug Administration (FDA) regardless of how similar they were to existing products. With the new draft guidance for labeling biosimilar products, the FDA hopes to remove potentially costly obstacles to getting these products to patients who need them.

Although the document is still a draft, it’s an important step to help encourage biosimilar products that would potentially keep healthcare costs low. The guidance for labeling includes an additional “biosimilar statement” that describes the biosimilar product’s relationship with the product it references. The FDA released an article titled “From Our Perspective: Biosimilar Labeling” that offers more insight into the draft.

National Cancer Moonshot Launches Online Engagement Platform for Researchers

While touring the United States’ leading cancer centers, Vice President Joe Biden discussed were the accessibility to data and breaking down research silos. As of April 16, the National Cancer Institute has launched an online engagement platform for cancer researchers. It’s an interactive, web-based service that allows researchers and the public to share ideas with the Blue Ribbon Panel of scientific experts who will work to inform the National Cancer Moonshot

The online platform aims to collect ideas from the research community, as well as the general public, concerning ideas for advancing the fight against cancer. Research ideas may be submitted in the following areas.

  • Clinical trials
  • Data sharing
  • Dissemination and population of sciences
  • Immunotherapy and immunoprevention
  • Pediatric cancer
  • Tumor evolution and progression
  • Other exceptional opportunities

Join a Virtual Lobby Day With the Patient Quality of Life Coalition 

On April 27, the Patient Quality of Life Coalition (PQLC) will be participating in a virtual lobby day to ask legislators to support the Palliative Care and Hospice Education and Training Act (PCHETA). This bill aims to establish palliative care and hospice education centers to provide nurses with the training they need to provide palliative care to patients in need. The bill also calls for fellowship programs that provide short-term intensive courses focused on palliative care. It would create special preferences in nurse education law for hospice and palliative nursing, along with establishing a national campaign to educate patients about the benefits of palliative care. 

Any nurse can participate in the virtual lobby day through the PQLC. The coalition’s website has information concerning important talking points and how to advocate for PCHETA. Oncology nurses know the great value of palliative care in a patient’s quality of life. ONS, along with 36 other organizations, has already voiced support for the legislation.