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Legal Minute: Drug Registrations that can’t be ignored
Manage episode 414139329 series 3506216
A tartalmat a Darshan Kulkarni biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a Darshan Kulkarni vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.
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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