Newsletter - January 27, 2022
FDA Suggested Ways For Including Patient Perspectives in Clinical Trials
The experiences and perspectives of patients and their caregivers could be invaluable in the design of clinical trials intended to evaluate a new product for them. However, the FDA expectations from the process used to involve patients in clinical trial design may create challenges for the sponsors and patients alike. In a new guidance document...Read More
FDA’s New Approvals Were Not Affected by the Pandemic
Last year FDA approved the same number of new drugs as the previous two years demonstrating that the pandemic related disruptions did not affect the timelines for the new drug approvals. Also, like previous years more than half of the approved new drugs were intended for rare or orphan diseases and almost three-fourths (74%)...Read More
FDA Suggested Ways For Including Patient Perspectives in Clinical Trials
The experiences and perspectives of patients and their caregivers could be invaluable in the design of clinical trials intended to evaluate a new product for them. However, the FDA expectations from the process used to involve patients in clinical trial design may create challenges for the sponsors and patients alike. In a new guidance document...Read More
FDA’s New Approvals Were Not Affected by the Pandemic
Last year FDA approved the same number of new drugs as the previous two years demonstrating that the pandemic related disruptions did not affect the timelines for the new drug approvals. Also, like previous years more than half of the approved new drugs were intended for rare or orphan diseases and almost three-fourths (74%)...Read More
