FTC Issues Final Rule Regarding Unqualified “Made in the USA” Label Claims
By T. Daniel Logan, Cynthia L. Meyer, and Jacqueline J. Chan On July 1, 2021, the Federal Trade Commission (“FTC” or “the … more
Insights + News
As FDA Emerges From the COVID-19 Pandemic, the Agency Revokes Various EUAs and Guidance Documents for Certain Respirators and Decontamination Systems
By Suzan Onel, Cynthia L. Meyer, and Justine E. Lenehan In our earlier Insight, we discussed FDA’s effort to expand the availability … more
KKB Attorney Samantha Hong to Speak at ACI Biosimilars & Innovator Biologics Summit
KKB Attorney Samantha Hong will be speaking at the ACI 12th (Virtual) Summit on Biosimilars and Innovator Biologics on June 22, 2021. Samantha will interview the FDA Keynote Speaker, Jessica … more
KKB Partner KS Reagan to Present on Investigational Device Exemptions (IDEs) at FDLI’s Introduction to Medical Device Law and Regulation Course
KKB Partner KS Reagan will be presenting at the Food and Drug Law Institute (FDLI)’s Introduction to Medical Device Law and Regulation course on … more
KKB Partner Will Woodlee to Discuss Potential Mandatory Product Listing Requirements at ACI’s Annual Legal, Regulatory & Compliance Forum on Dietary Supplements
KKB Partner Will Woodlee will speak on June 8, 2021, at 3:45 pm ET during the American Conference Institute’s (ACI’s) virtual 9th Annual Legal, … more
KKB Partner Suzan Onel to Discuss Medical Technologies in Digital Health as part of AU Health Law and Policy Summer Speaker Series
KKB Partner Suzan Onel will be speaking at American University Washington College of Law’s Health Law and Policy Summer Speaker Series on … more
KKB Attorneys Author Chapters in FDLI “Top Cases” Publication, 2021 Edition
The Food and Drug Law Institute (FDLI) recently published the latest annual installment of its popular “top cases” publication, Top Food and Drug … more
Just Six Months Later, FDA (Somewhat) Revives its Unapproved New Drugs Initiative
By: KS Reagan, Peter Mathers, and Samantha Hong On May 27, 2021, HHS emphatically and unequivocally withdrew the agency’s November 2020 notice … more
A Slightly-Hazy Crystal Ball: The Future of FDA Inspections in the (Continuing) Era of COVID-19
By: Jacqueline J. Chan and Samantha Hong Like all entities faced with navigating the challenges of resuming operations as the COVID-19 pandemic … more
U.S. Supreme Court Blocks Easy Path for FTC to Obtain Monetary Remedies in Equity
By: T. Daniel Logan and Jacqueline J. Chan Since 1973, the Federal Trade Commission (“the Commission”) has had the authority, under Section … more