Bethany Hills spoke to Law360 for an article that answers the most significant questions health care and life sciences clients are asking attorneys.
When asked how the U.S. Food and Drug Administration’s postponement of foreign inspections might affect companies, Bethany advised that open warning letters, pending product approvals, and scheduled inspections are all going to be “impacted to varying degrees,” adding that while agency officials will tackle certain medium- and high-risk issues with desk audits, “there will inevitably be a backlog of inspections that will have a lasting impact.”
Read the full article.