News & Insights

FDA Resumes Medical Device Inspections It is much more likely that you noticed changes to what the FDA has been doing during the COVID-19 pandemic rather than changes to what it has not been doing.  One example of what they have been doing is the review and issuance of Emergency Use Authorizations. …

As FDA is postponing most foreign inspections through April in response to the COVID-19 outbreak, there will undoubtedly be an impact on product application reviews and biennial GMP inspection approvals. During this time, FDA has committed to take interim measures that may include inspection waivers…