Category Archives: COVID19

Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading

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T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading

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