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VQIP application portal will open October 1st for the Fiscal Year 2020 benefit period
  • Keller and Heckman LLP
  • USA
  • September 24 2018

The Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP). VQIP is intended to expedite the review and

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A
  • Hogan Lovells
  • USA
  • September 21 2018

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities
  • Knobbe Martens
  • USA, European Union
  • September 19 2018

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that

Impending Tariffs on China to Impact Manufacturers of Dietary Supplements, OTC Drugs, Cosmetics
  • Morgan Lewis
  • USA, China
  • September 19 2018

Newly approved tariffs would impose 10 to eventual 25 tariffs on hundreds of chemical ingredients imported from China used for many FDA-regulated

FDA announces new export certification program
  • Keller and Heckman LLP
  • USA
  • September 4 2018

The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for

Serving the Legal Needs of Dietary Supplement Companies
  • Porzio Bromberg & Newman PC
  • USA
  • July 17 2018

A variety of legal and regulatory challenges exist in the dietary supplement industry, including federal and state legislatures, agencies and courts. Some recent significant developments are summarized below....

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month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA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