The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The deal is expected to close in the second half of 2020, but one analyst expects the transaction will raise antitrust issues in the United States.
Start-up Ariste Medical has developed technology to reduce surgical site infections and transform implants into combination products.
When preparing a regulatory submission, there are a couple of critical elements to consider.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.