Pitfalls of using third-party hubs for reimbursement assistance, sharing preapproval data with patient groups, and promoting biosimilars with labeling carveouts are among the concerns noted by panelists at FDLI conference.

The average return for companies that went public in the US through the end of September was 49.4% as of 5 October. The fourth quarter started with four additional initial public offerings on 1 October.

Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

Legal experts say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.