• Key Regulatory Agencies in Pharma M&A

  • 2025/02/20
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Key Regulatory Agencies in Pharma M&A

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  • When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay informed—compliance isn’t optional.


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あらすじ・解説

When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay informed—compliance isn’t optional.


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