FDA Gives Guidance on Manufacturing During COVID-19
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
On September 11, 2020, FDA published guidance to help manufacturers of drugs and biologics transition their manufacturing operations impacted by the COVID-19 pandemic back to “normal”. In the guidance, the agency provides recommendations for prioritizing products as normal operations resume and for remediation of current good manufacturing practice (CGMP) activities impacted by the pandemic.
During the pandemic, manufacturing operations may have been impacted by employee illness, travel restrictions, plant closures, and disruptions to the supply chain. The guidance provides detailed information for addressing CGMP deviations, developing a plan to resume normal manufacturing activities, and prioritizing activities. The document includes a list of examples where remediation may be necessary.
Source: FDA
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
