By Michael McCaughan
"I don’t think there are any rules of the road here." That is how Josh Ofman, Amgen Inc.’s VP-global coverage...
Taking on CMS
Listen to this article
Amgen and J&J have billions of dollars at stake in the battle to convince CMS to change its coverage proposal for EPO in cancer patients. Win or lose, their efforts will be a valuable case study for any other manufacturer that fi nds itself facing an adverse reimbursement policy.
Learn what's happening at the US FDA. On the go.
More from Clinical Trials
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
• By
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
• By
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
More from R&D
• By
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
• By
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
• By
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.