Welcomed New Developments in FDA’s Regulation of Digital Health Products
By Suzan Onel On July 27, 2017, the Food and Drug Administration (“FDA”) announced the issuance of a Digital Health Innovation Action … more
By Suzan Onel On July 27, 2017, the Food and Drug Administration (“FDA”) announced the issuance of a Digital Health Innovation Action … more
By Stacy Ehrlich On April 19, 2017, the Federal Trade Commission (FTC) sent letters to over 90 marketers and so-called “influencers,” … more
The Food and Drug Law Institute recently published the latest annual installment of its popular “top cases” publication, Top Food and Drug Cases, 2016 … more
The Food and Drug Law Institute recently published the latest annual installment of its popular “top cases” publication, Top Food and Drug Cases, 2016 … more
KKB is pleased to announce that the U.S. State Department has invited KKB partner Suzan Onel to be the keynote speaker at … more
By Celeste D. Wheeler FDA’s recent aggressive enforcement action against homeopathic teething tablets and gels brings into sharp focus the dilemma facing … more
By: Cynthia L. Meyer This week, the U.S. Food and Drug Administration (“FDA” or “Agency”) announced it is further delaying by one … more
On February 8, 2017, KKB partners Stacy Ehrlich and Will Woodlee presented a webinar on FDA ingredient listing submissions for e-liquid products. Hosted … more
As FDA has gained more experience with inspections for good manufacturing practices (GMPs) for dietary supplements, its processes have become more sophisticated. The … more
By: Suzan Onel[*] On December 13, 2016, President Obama signed the 21st Century Cures Act (Public Law No. 114-255) (“the Act”) into … more