RESOURCES

FDA’s New Plan for Tobacco and Nicotine Regulation
August 3, 2017 | 10:33 AM

By Stacy L. Ehrlich On July 29, 2017, the new FDA Commissioner, Dr. Scott Gottlieb, announced a new comprehensive plan for tobacco and nicotine regulation…

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Welcomed New Developments in FDA’s Regulation of Digital Health Products
August 2, 2017 | 10:29 AM

By Suzan Onel On July 27, 2017, the Food and Drug Administration (“FDA”) announced the issuance of a Digital Health Innovation Action Plan (“Action Plan”)…

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Social Media Influencers: #headsup, the FTC Has Its Eye on You
May 26, 2017 | 2:21 PM

  By Stacy Ehrlich On April 19, 2017, the Federal Trade Commission (FTC) sent letters to over 90 marketers and so-called “influencers,” reminding them that…

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KKB Partners Author FDLI Chapter on Philip Morris USA Inc. v. FDA
May 21, 2017 | 11:58 AM

The Food and Drug Law Institute recently published the latest annual installment of its popular "top cases" publication, Top Food and Drug Cases, 2016 & Cases to…

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Jacqueline Chan Authors FDLI Chapter on Significant Settlements
May 21, 2017 | 11:49 AM

The Food and Drug Law Institute recently published the latest annual installment of its popular "top cases" publication, Top Food and Drug Cases, 2016 & Cases to…

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KKB PARTNER SUZAN ONEL INVITED TO BE KEYNOTE SPEAKER IN U.S. EMBASSY SPONSORED CONFERENCE IN HONDURAS
May 16, 2017 | 3:02 PM

KKB is pleased to announce that the U.S. State Department has invited KKB partner Suzan Onel to be the keynote speaker at a regional conference…

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Are Changes on the Horizon for Homeopathic Drugs? Navigating the Regulatory Landscape as FDA and FTC Waters Get Choppier
April 21, 2017 | 3:56 PM

By Celeste D. Wheeler FDA’s recent aggressive enforcement action against homeopathic teething tablets and gels brings into sharp focus the dilemma facing manufacturers of homeopathic…

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Off-Label Communications and Intended Use: What’s Happening Now?
March 23, 2017 | 4:56 PM

By:  Cynthia L. Meyer This week, the U.S. Food and Drug Administration (“FDA” or “Agency”) announced it is further delaying by one year the effective…

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KKB Partners Present VTA Webinar on E-Liquid Ingredient Listings
February 11, 2017 | 2:47 PM

On February 8, 2017, KKB partners Stacy Ehrlich and Will Woodlee presented a webinar on FDA ingredient listing submissions for e-liquid products.  Hosted by the Vapor…

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KKB Partner Tony Young Participates in Podcast on Dietary Supplement GMP Inspections
February 5, 2017 | 4:34 PM

As FDA has gained more experience with inspections for good manufacturing practices (GMPs) for dietary supplements, its processes have become more sophisticated.  The agency knows which…

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