The Regulatory Roundup

Food & beverage, cannabis, tobacco, life sciences, and agriculture regulatory updates

Latest from The Regulatory Roundup - Page 5

Attorney General Sessions Rescinds Obama-Era Policies That Allowed State-Authorized Cannabis Activity to Flourish, Including Cole Memo

January 4, 2018

Earlier today, Attorney General Jeff Sessions issued a memorandum to all U.S. Attorneys in which he rescinded, effective immediately, several previous U.S. Department of

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The Regulatory Roundup

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

By nschuman

December 7, 2017

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant

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The Regulatory Roundup

Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

By ssteinig

November 8, 2017

Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). In

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The Regulatory Roundup

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

By ssteinig

November 2, 2017

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist,

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The Regulatory Roundup

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device Development Tool

By nschuman

October 25, 2017

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device Development Tool

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation

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The Regulatory Roundup

FDA Agrees to Enforce Menu Labeling Rule in May 2018, Delays New Nutrition Facts Label Compliance Deadline Until January 2020

By nschuman

October 2, 2017

FDA Agrees to Enforce Menu Labeling Rule in May 2018, Delays New Nutrition Facts Label Compliance Deadline Until January 2020

As discussed previously, earlier this year, the U.S. Food and Drug Administration (FDA or the Agency) delayed its Menu

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The Regulatory Roundup

FDA Commissioner Touts Seamless Clinical Trials, Use of Modeling and Simulation As Ways to Lower Drug Costs

By nschuman

September 12, 2017

FDA Commissioner Touts Seamless Clinical Trials, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency)

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