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An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer

FDA Law Blog

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.

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How to Make the Case for E-Discovery Software

InHouseOps

Yet, they don’t always feel empowered to advocate for the tools they need, even when having these tools will save time, reduce risk and even lower the company’s legal spend. Your paralegal spends 16 hours per week manually tracking responses for legal hold notifications and following up with custodians. For example: Example 1.