Legal Minute: Drug Registrations that can’t be ignored
DarshanTalks Podcast
English - April 23, 2024 18:00 - 56 seconds - 716 KB - ★★★★★ - 1 ratingNews pharma medical devices fda laws regulations guidances clinical research advertising mergers acquisitions Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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.