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FDA Secures Additional Time to Submit Court-Compelled Expedited Schedule for a Final Graphic Health Warnings Rule
  • Troutman Sanders LLP
  • USA
  • September 28 2018

As a follow-up to our earlier blog post on this topic, the FDA now has until October 5, 2018 to provide an expedited schedule for the issuance of a

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

DOJ Announces Revised Opioid Anti-Diversion Policy
  • FisherBroyles LLP
  • USA
  • July 16 2018

Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
  • Knobbe Martens
  • USA
  • July 16 2018

References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed because

FTC and House Start Working Together to Address CPSC-related Connected Technology Issues - Stakeholders Should Prepare for Future Government-Wide Cooperation
  • Venable LLP
  • USA
  • June 19 2018

Robust conversations about IoT, smart technology, and product safety continue across the federal government. On May 16, 2018, the Consumer Product

FDA Releases Guidance on Dietary Fiber
  • Keller and Heckman LLP
  • USA
  • June 15 2018

Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or

FDA Seeks Comments on Potential Marijuana Reclassification Under International Drug Control Treaty
  • Jackson Lewis PC
  • USA
  • April 19 2018

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential

FDA Proposes New Class II Device Marketing Pathway
  • Arent Fox LLP
  • USA
  • April 17 2018

The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to

In Rare Move, FDA Debars Company from Importing Food
  • Arent Fox LLP
  • USA
  • March 15 2018

For the first time in recent history, the Food and Drug Administration has debarred a foreign firm from importing food into the United States. The

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative
  • K&L Gates
  • USA
  • October 16 2017

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and