Newsletter - December 1, 2022
FDA Updates List of Approved Medical Device Development Tools
It is not widely known that FDA publishes on its website a list of qualified tools that developers of medical devices can use to generate supporting information for their market approval applications. These tools have been vetted by FDA as “well-defined and reliable measure of a specific concept” and hence interpretations...Read More
CDC Revised Opioid Prescription Guidelines to Address Overkill
In 2016, CDC published a list of recommendations for physicians prescribing opioid pain medications, to assist in judicious and diligent prescription of these critically needed drugs with high abuse potential. Five years later, CDC now believes that these “voluntary” recommendations may have hurt patient care by creating...Read More
FDA Updates List of Approved Medical Device Development Tools
It is not widely known that FDA publishes on its website a list of qualified tools that developers of medical devices can use to generate supporting information for their market approval applications. These tools have been vetted by FDA as “well-defined and reliable measure of a specific concept” and hence interpretations...Read More
CDC Revised Opioid Prescription Guidelines to Address Overkill
In 2016, CDC published a list of recommendations for physicians prescribing opioid pain medications, to assist in judicious and diligent prescription of these critically needed drugs with high abuse potential. Five years later, CDC now believes that these “voluntary” recommendations may have hurt patient care by creating...Read More
