Protecting Rx Manufacturing From COVID: US FDA Offers Directions For Firms
Guidance provides agency’s expectations for keeping virus out of drugs and facilities by protecting, monitoring, and excluding workers.
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The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
The US Food and Drug Administration has issued final guidance aimed at encouraging manufacturers of so-called "medically necessary drug products" and their raw materials and components to develop contingency production plans for use during emergencies that result in high absenteeism at production facilities.
The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.