DarshanTalks Podcast

Legal Minute: Drug Registrations that can’t be ignored

April 23, 2024 Darshan Kulkarni
Legal Minute: Drug Registrations that can’t be ignored
DarshanTalks Podcast
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DarshanTalks Podcast
Legal Minute: Drug Registrations that can’t be ignored
Apr 23, 2024
Darshan Kulkarni

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and local authorities is often overlooked by these companies, who may mistakenly believe that FDA registration suffices. However, failure to register appropriately with state and local authorities could lead to sales restrictions within those jurisdictions. Each state has its own criteria for registration, which can vary widely. Depending on the circumstances, a company may need to register as a manufacturer, distributor, or wholesaler. 

Consulting a regulatory attorney is essential to ensure proper registration and avoid potential complications down the line.




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Show Notes

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and local authorities is often overlooked by these companies, who may mistakenly believe that FDA registration suffices. However, failure to register appropriately with state and local authorities could lead to sales restrictions within those jurisdictions. Each state has its own criteria for registration, which can vary widely. Depending on the circumstances, a company may need to register as a manufacturer, distributor, or wholesaler. 

Consulting a regulatory attorney is essential to ensure proper registration and avoid potential complications down the line.




Support the Show.