News & Insights
CGMP Compliance Challenges with COVID-19 Infection
With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry…
FDA Postpones Foreign Inspections
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…
New Policy for SARS–CoV–2 Serology Tests
FDA significantly tightened oversight on SARS‐COV‐2 serology tests by publishing new policy requiring all serology tests to be reviewed and approved under Emergency Use Authorization (EUA). In a rush to make serology antibody tests available as quickly as possible, FDA previously allowed SARSCOV‐ 2…