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About The Webinar

The FDA is the guardian of public health in the U.S., regulating drugs, biologics, medical devices, food and feed, cosmetics, tobacco, and radiation-emitting devices. For importers, regulatory compliance begins before goods even reach the U.S. Understanding FDA regulations and developing an FDA import compliance program is therefore critically important to your global supply chain.

Join former FDA Director of Import Operations & Policy Domenic Veneziano and ST&R associate Andrea Jeglum for a discussion on how the FDA regulations affect your imports and how best to mitigate compliance risks.

Key Topics

  • FDA overview and regulatory framework
  • FDA declaration at U.S. entry
  • FDA review of importer’s entry declaration
  • FDA entry decisions
  • FDA import alerts
  • FDA prior notice requirements
  • FDA affirmation of compliance information
  • building and sustaining a compliant import process

Speakers

Andrea Jeglum

Andrea K. Jeglum

Associate
781-559-0140 ajeglum@strtrade.com

ANDREA K. JEGLUM is an associate with Sandler, Travis & Rosenberg, P.A., located in the Boston area. She concentrates her practice on customs compliance matters including tariff classification, country of origin, valuation, trade agreements, foreign-trade zones, and duty reduction programs. She also helps clients meet U.S. requirements concerning trade in biopharma, agro-chemicals, and animal products, including endangered species, as well as export filings and enforcement measures.  

781-559-0140 ajeglum@strtrade.com

Domenic J. Veneziano

Domenic J. Veneziano

Independent FDA Regulatory and Strategic Consultant
202-734-3939 dveneziano@strtrade.com

DOMENIC J. VENEZIANO is an Independent FDA Regulatory and Strategic Consultant to Sandler, Travis & Rosenberg, P.A. He works closely with ST&R’s FDA Practice Group to advise importers, exporters, producers, and distributors of commodities regulated by the Food and Drug Administration to ensure that they and their facilities comply with FDA laws and regulations.

202-734-3939 dveneziano@strtrade.com

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