Katrina’s Blog™

Focus on the Total Product Life Cycle and Promoting Newer Predicate DevicesIn April 2018 the FDA published the Medical Device Safety Action Plan in which the agency first described its current framework for ensuring both existing and new medical devices are safe and...

In December, CDRH published a report by consultant group Booz Allen Hamilton evaluating the results of the plans established by CDRH to improve the medical device review process. These plans were based on the recommendations from phase 1 of the assessment (also...

The primary tool used by the FDA for drug post-market safety surveillance is the Sentinel System. This system, authorized in 2007 in the FDA Amendments Act, started with a pilot in 2009 and as of 2016 is a fully operational tool for linking and analyzing safety data...

Let’s say your company has a new drug with some exciting discovery and animal data, and you are planning for clinical development, including the Investigational New Drug (IND) application with the FDA. Do you have questions about the advisability and feasibility of a...

Patient focused drug development is a recent interest at the FDA following the adoption of the 21stCentury Cures Act. Sections 3001 to 3004 of this act add the definition of patient experience data to the FD&C Act and tells the FDA how to work with sponsors using...