Katrina’s Blog™

A clear understanding the total product life cycle of a medical device requires much more data than is available in routine regulatory submissions. The FDA has recognized that a national system to collect and analyze Real World Data (RWD) and convert it to Real World...

The acronym REMS stands for Risk Evaluation and Mitigation Strategy, a component of approval that may be required when the FDA determines that additional information beyond prescribing information is necessary to ensure that the benefits of a drug outweigh its risks....

Proposal Comment Period ExtendedOn April 11ththe FDA extended the comment period for call for comments on how to shift industry and agency focus towards the development and use of more modern predicate devices for determinations of Substantial Equivalence (following...

In case you haven’t noticed, cybersecurity for medical devices is a subject of concern for the FDA. The issue has been clarified this week by the announcement of cybersecurity vulnerabilities affecting Medtronic Implantable Cardiac Devices, Programmers, and Home...

On March 21, 2019 the FDA issued an alert about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma. The alert is based on review of data from the Bellini clinical trial (NCT02755597, Study...