Category: FDA

PDA/FDA

See You at the PDA/FDA Conference

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).

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A New FDA Model

The New FDA GMP Inspection Model

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.

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5 Ways Manufacturing Quality Problems Can Take Down a Company

5 Ways Manufacturing Quality Problems Can Take Down a Company

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New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for

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