FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic
Executive Summary
FDA guidance updated in mid-April offered workarounds for trial sponsors attempting to conduct clinical studies in a time of travel limitations, staffing changes and heightened patient safety issues. For trials involving complex products and administration, such as cell and gene therapies, sponsors must determine whether modified protocols can still maintain trial integrity. If not, it may be time to press pause.
You may also be interested in...
Khushboo Sharma: Improving Regulatory Science, From Industry To FDA And Back
From pre-med to pharma lab rat to deputy director of operations at the FDA, Khushboo Sharma, a 2021 In Vivo Rising Leader and current VP of science and regulatory affairs at BIO, has spent her career pursuing a goal she says the FDA and biopharma industry have in common: ensuring that innovative drugs get to patients.
Data-Sharing Key To US Supply Chain Resilience And Keeping Drug Costs Under Control
Aside from a few high-profile exceptions, the biopharma industry supply chain has remained secure and resilient during the COVID-19 pandemic, outperforming retail and consumer goods. Chip Davis, Jr., head of the Healthcare Distribution Alliance, spoke with In Vivo about the need for a long-term industrial policy for drug manufacturing, real-time data-sharing and transparency in the supply chain, and minimizing disruptions.
Microsoft’s Strategy In Health Care: Connection, Not Disruption
Through an ever-growing number of partnerships, grants and investments in the health care sector, Microsoft is taking a lead from behind approach to improve and expand interoperability, increase data security and analytics, and provide partners with tools, technology, and a platform for growth.