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⍰ ASK Are there any specific regulations for companies in the healthcare and pharmaceutical industry during formation in the USA?

Companies in this sector must handle regulations from federal agencies like the FDA and CMS. The FDA regulates and approves pharmaceuticals, medical devices, and biologics, ensuring high safety and efficacy standards.

Healthcare companies, including hospitals, must follow HIPAA, protecting patient health information.

Pharmaceutical companies deal with extra regulations on drug manufacturing labeling and marketing. The DEA oversees controlled substances.

These rules create a complex regulatory landscape that companies in the industry need to navigate for compliance.
 

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