Drug Distributors Mitigate Coronavirus
For most patients, drug distributors – companies that provide, control and manage drug supplies – operate as an unseen but critical link in the supply chain. In the context of a global pandemic, however, drug distributors play an even bigger role in helping to ensure that pharmacies, health systems and ultimately patients have access to essential medicines.
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The German biotech firm has denied receiving any offer from the Trump administration in a wide-ranging conference call that also addressed recent changes at the top, its clinical timeline for a coronavirus vaccine and new funds from the European Commission to boost production.
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.