Govzilla is on the road again! We hope to see you at the 27th Annual PDA/FDA Joint Regulatory Conference in Washington, DC from September 24th-26th. Here is the full list of speakers and events happening at the conference (including the one we wouldn’t miss).
While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
The FDA Center for Device and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of
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The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals
We took a snapshot of the 3 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to have
We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to prevent