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Cannabis Industry Standards: ASTM Considers Filling the Void
  • Arent Fox LLP
  • USA
  • February 24 2017

Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations


Substance Abuse Medical Record Privacy Rules Updated For The First Time in Nearly 30 Years
  • Arent Fox LLP
  • USA
  • February 22 2017

For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the


FDA Schedules Public Meeting to Discuss “Healthy” Food Labeling Claims
  • Arent Fox LLP
  • USA
  • February 22 2017

The Food and Drug Administration has just announced that it will hold a Public Meeting on March 9, 2017 to discuss use of the term “healthy” in the


Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices
  • Arent Fox LLP
  • USA
  • February 16 2017

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with


Trump’s 2-for-1 Executive Order, its Impact on FDA, and the Significance of “Significant”
  • Arent Fox LLP
  • USA
  • February 10 2017

On the heels of a January 20, 2017 memorandum freezing the release of any new or pending regulations until they have been reviewed and approved by


Trump’s 2-for-1 Executive Order and its Impact on FDA
  • Arent Fox LLP
  • USA
  • February 3 2017

On the heels of a January 20, 2017 memorandum freezing the release of any new or pending regulations until they have been reviewed and approved by


FDA Issues Draft Guidance on Lead Levels in Cosmetics
  • Arent Fox LLP
  • USA
  • February 2 2017

The US Food and Drug Administration recently issued draft guidance establishing an upper limit for lead levels in externally applied cosmetics of 10


The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval
  • Arent Fox LLP
  • USA
  • January 23 2017

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities -


USDA and FDA Issue Proposals to Regulate Genome Edited Plants, Animals, and Microorganisms
  • Arent Fox LLP
  • USA
  • January 19 2017

Today, January 19, 2017, FDA and USDA published a flurry of new policy documents related to the agencies’ regulation of plants, animals, and


How Millennials Will Change Health Care IT
  • Arent Fox LLP
  • USA
  • January 19 2017

Millennials want the same seamless digital experience in health care that they have in other aspects of their lives. At the same time, having grown