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Ensuring the Safety of Food Contact Materials: GMPs and Beyond
  • Keller and Heckman LLP
  • USA
  • June 20 2018

The U.S. Food and Drug Administration’s (FDA) announced in January 2018 that it was exercising enforcement discretion with respect to the Food Safety


Hatch-Waxman and BPCIA Developments in May 2018
  • Morrison & Foerster LLP
  • USA
  • June 6 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA


FDA Encourages Importer Preparation for Next VQIP Application Cycle
  • Keller and Heckman LLP
  • USA
  • May 29 2018

As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and


US - APHIS to change policy for FDA approved human medical devices containing animal derived ingredients
  • Baker McKenzie
  • USA
  • May 25 2018

In a Stakeholder Importer Alert dated May 31, 2018, the Animal and Plant Health Inspection Service (APHIS), advised that in consultation with the Food


FDA’s ‘Data Dashboard’ Expansion Makes Supply-Chain Verification Searches Easier
  • Keller and Heckman LLP
  • USA
  • May 21 2018

Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals


ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval
  • Jones Day
  • USA
  • May 17 2018

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be


FDA and USDA Action Implements US Nutrition Action Plan and Federal Food Labeling Policy Agenda
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • May 14 2018

This year has been marked by robust efforts by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) to


Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • April 9 2018

Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid


FSMA Implementation Update (March 2018)
  • Hogan Lovells
  • USA
  • March 26 2018

There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). This memorandum summarizes the


FDA Publishes List of FSVP Importers Under FSMA
  • Hogan Lovells
  • USA
  • March 19 2018

The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in