Benjamin England, FDAImports.com Founder and CEO, and Bill Nychis, Senior Regulatory Advisor, recently co-presented a webinar entitled “FDA Import Holds: New Powers to Control Products.”
Mr. England provided an overview of FDA’s drug importation enforcement authority, including FDA Detentions and Refusals, PREDICT and PLAIR (Pre-Launch Activities Importation Requests), and discussed surviving an import hold crisis and some strategies for communicating with FDA. Mr. Nychis provided an overview of FDASIA, and discussed Import Alerts relative to drug importers and the import documents unique to drug imports.
Mr. Nychis stressed, “FDA’s job is to take regulatory actions against companies and products. Don’t be afraid of challenging them!” Ben England commented, “District compliance officers usually get policy decisions from the Office of Compliance in the Center for Drug Evaluation and Research (CDER). However, importers should not assume that CDER is always or even mostly correct.”
Webinar attendees reported that the presentation helped them to better understand the U.S. drug import and export laws and FDA’s concerns. This knowledge is essential to implement and streamline a drug importation strategy, and will help a firm identify and address its operational weaknesses before importing into the U.S.
FDAImports.com provides door-to-door regulatory consultation and legal services from pre-marketing to importation and distribution in the United States. Expanding your market into the highly-regulated United States can be a formidable task; we can definitely help you ease and accelerate the process. Contact us today to learn more about how we can help you with drug import issues.
Benjamin England is a 17-year veteran of the FDA. His last position held was Regulatory Counsel (Attorney) to FDA’s Associate Commissioner for Regulatory Affairs. William Nychis is a 40+ year FDA-veteran, with decades of experience dealing with FDA drug compliance. He has specialized for more than a decade in imports and exports at CDER.
