In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG&#x27;s Corporate &amp; Finance practice and Chair of the firm&#x27;s International Compliance &amp; Risk team. Together, they discuss how pharmaceutical and biologics companies should rethink global supply chains in light of the Section 232 tariffs affecting patented pharmaceutical products; common customs and trade compliance issues with imported FDA-regulated goods; legal risk-mapping to avoid detentions, refusals, and unexpected duty exposure; potential tariff actions impacting medical devices; how shifting U.S. trade policies are changing global supply chains for pharmaceuticals, biologics, and medical devices; the impact of heightened enforcement on forced labor in global supply chains; how industry should manage sanctions and export control exposure; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.

FDA Legal, Regulatory &amp; Compliance Issues, Part 2: Customs Regulation &amp; International Trade

FDA Watch

Recent enforcement actions have really shown that failing to screen upstream vendors can lead to repeated dealings with specially designated nationals through intermediaries and even when the customer facing side of the business may look positive. So really that upstream screening of your vendors is so critical.

Welcome to a very special episode of FDA Watch. I'm your host, Wayne Pines. As you know, we're the leading independent nonpartisan podcast on FDA. This episode is another installment in one of our signature multi-episode series that we produce in collaboration with law firms and other organizations. This is the second in a four part series we're doing with the law firm, our nonpartisan.

Now, Gold and Gregory, very well known law firm and has a wide practice in the FDA area. In the first part of the series, we focused on the current state of enforcement by FDA and the Department of Justice. In today's episode, we'll be discussing customs regulation and international trade. And we have just the right people to take us on that journey. So let's meet them now.

First guest, Luis Aranda Jr. Luis is a partner and co-chair of international trade at AGG. He helps companies navigate tariffs, customs, export controls, and sanctions. And he represents clients before key regulatory agencies and the courts. And he's well known as a speaker and author on global trade issues.

Also joining us today is Allison Raley. She's a partner in AGG's corporate and finance practice. She's chair of the firm's international compliance and risk team. She advises pharmaceutical, life sciences, cosmetics, and other multinational companies on cross-border regulatory compliance and international business matters.

FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade

Read the full transcript

The candid version is on a podcast,
not the earnings call.

FDA Legal, Regulatory &amp; Compliance Issues, Part 2: Customs Regulation &amp; International Trade

Read the full transcript

The candid version is on a podcast, not the earnings call.

FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade

The candid version is on a podcast,
not the earnings call.