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Supply Chains (2)

FDA, Supply Chains, COVID 19, Draft Guidance, Medical Device Manufacturers, Regulatory and Compliance

FDA Attempts to Prevent Future Supply Chain Shortages with a Move towards New Requirements

January 19, 2022

The U.S. Food and Drug Administration (FDA) released a new guidance document on January 11, 2022 titled “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a...

1 minute read

FDA, Supply Chains, COVID 19, Department of Justice (DOJ), Draft Guidance, Medical Device Manufacturers, Regulatory and Compliance

DOJ to Ramp up Scrutiny of Clinical Trial Fraud

January 19, 2022

The U.S. Department of Justice has recently announced several actions in connection with alleged clinical trial fraud, but going forward, this point of emphasis will not be incidental for...

2 minute read

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Supply Chains (2)

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FDA Attempts to Prevent Future Supply Chain Shortages with a Move towards New Requirements

DOJ to Ramp up Scrutiny of Clinical Trial Fraud