With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
Some areas that companies should consider include the following:
- Supply chain disruption, including active pharmaceutical ingredient (API) and excipient shortages
- Drug shortages and related FDA notices
- FDA inspection priority shifts
- Potential impacts on import surveillance
- Delays in FDA’s review of pending drug applications
- Possible impacts on clinical trials and necessary changes to relevant trial documents
- The impact on drug promotion and new risks created by the changing landscape
For further analysis, please see our March 13 LawFlash, Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries.