Articles: 1-10 of 109

FDA Objects to Branded Pre-Approval YouTube Video

USA - January 3 2017 We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agent/subsidiary of Indian…

U.S. Antitrust Enforcers Weigh-In on Competitive Benefits of Telehealth

USA - December 7 2016 The top antitrust enforcers in the U.S. — the Department of Justice Antitrust Division (“DOJ”) and the Federal Trade Commission (“FTC”) — are tasked…

FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device

USA - November 22 2016 Last month, the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for Industry…

FTC Reverses Course on Soundboard Technology to Curtail Abusive Telemarketing Calls

USA - November 22 2016 This month, the FTC issued a Staff Opinion Letter that will revoke a prior opinion letter and will now bring outbound telemarketing calls that…

FTC Issues Enforcement Policy Statement on Marketing Claims for Over-the-Counter Homeopathic Drugs

USA - November 17 2016 On November 15, 2016, the Federal Trade Commission (FTC) released a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC)…

Avoid Sticky “Made in U.S.A” Situations

USA - October 31 2016 The latest in a line of Federal Trade Commission (FTC) enforcement actions challenging “Made in USA” claims by manufacturers was recently resolved…

FDA Initiates Its “Healthy” Review of Nutrient Content Claims

USA - October 5 2016 On September 28, the U.S. Food and Drug Administration (FDA or the Agency) published a Request for Information regarding FDA’s intent to update the…

New Changes to Proposition 65 “Safe Harbor” Warnings

USA - September 14 2016 On August 30, 2016, the California Office of Administrative Law approved California’s nearly three-year effort to overhaul Proposition 65’s…

CPSC Proposes to Reduce Testing Requirements for Phthalates

USA - September 8 2016 On August 17, 2016, the Consumer Product Safety Commission (CPSC) issued a notice of proposed rulemaking that would reduce the burden of testing for…

CPSC Proposes to Reduce Testing Requirements for Phthalates

USA - September 8 2016 On August 17, 2016, the Consumer Product Safety Commission (CPSC) issued a notice of proposed rulemaking that would reduce the burden of testing for…