China Tightens Disease Control Oversight In Latest Overhaul

Source : 'The Pink Sheet'

In one unseasonal chilly day in March, the head of China Center for Disease Control and Prevention Gao Fu found himself in hot water after saying the efficacy of protection...

World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments

Source : 'The Pink Sheet'

Regulatory authorities say they are likely to keep using remote alternatives to site inspections even after post-pandemic travel resumes, but for different reasons and probably to different degrees.

Importantly, they are...

Coronavirus Notebook: 1.2bn Vaccines Produced Worldwide, ROVI To Double Moderna Capacity, Valneva starts UK Phase II/III trial

Source : 'The Pink Sheet'

As of 26 April, just under 1.2 billion COVID-19 vaccine doses had been manufactured worldwide since rollout began in November 2020. Almost 415.8 million of those doses were produced in...

FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools

Source : 'The Pink Sheet'

Alternative tools allowed the US Food and Drug Administration to avoid a substantial number of prior approval inspections during the coronavirus pandemic, potentially helping cement their use in the post-COVID-19...

US FDA Facility Records Review Evolved Into More Formal Process As Pandemic Continued

Source : 'The Pink Sheet'

The US Food and Drug Administration’s records request process that substituted for many facility inspections during the coronavirus pandemic began as a somewhat haphazard practice before becoming a more formal...