Coronavirus Prompts FDA to Cancel Travel, Postpone Inspections and Meetings

Regulatory NewsRegulatory News | 10 March 2020 |  By 

As a precaution amid the global coronavirus outbreak, the US Food and Drug Administration (FDA) on Tuesday canceled all foreign travel by agency officials and said it is limiting domestic travel to “mission critical only” through April.
FDA Commissioner Stephen Hahn also said the agency will postpone most foreign inspections, though some “will still be considered on a case-by-case basis.” Last month, FDA stopped conducting inspections in China while the outbreak was mostly contained within the country.
However, within the last two weeks, cases of the respiratory illness outside China have increased tenfold, with significant outbreaks occurring in Italy, Iran, Japan and South Korea. The US has also seen an increase in cases, with hundreds of cases reported along the West Coast and in New York state.
Hahn said the agency is “aware of how this action may impact other FDA responsibilities, including product application reviews,” which often include a preapproval inspection as part of the review process.
In the meantime, Hahn said the agency will use “alternative tools and methods” to oversee imported goods, such as examining products at the border, reviewing firms’ compliance history and requesting records “in advance of or in lieu of” on-site inspections.
In an email to staff, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said “The interruption in travel will temporarily alter how we do business. We need to maintain continuity of operations and accomplish as much of our work as possible.”
Woodcock also said that CDER-organized meetings, conferences and workshops will be postponed or canceled through April and directed staff to hold meetings with external stakeholders via teleconference if possible.
A meeting on patient-focused drug development for stimulant use disorder scheduled for Tuesday was postponed on short notice Monday, and the agency has postponed two other meetings originally slated for this week, the Nonprescription Drugs Advisory Committee meeting and the US-Japan Cellular and Gene Therapy Conference.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy