KKB Attorneys Author Chapters in FDLI “Top Cases” Publication
The Food and Drug Law Institute recently published the latest annual installment of its popular “top cases” publication, Top Food and Drug Cases, 2017 … more
Insights + News
With 55% Market Share and the Creation of a New Verb (“JUULing”), JUUL is Now at the Center of a Firestorm (Vaporstorm?) of Attention
By Stacy Ehrlich On April 24, 2018, FDA announced a number of new actions relating to youth access to and use of … more
KKB Partner Stacy Ehrlich Featured in Washington Lawyer Article
KKB partner Stacy Ehrlich and her husband Mark Ehrlich were recently featured in the Washington Lawyer cover story “Finding Fulfillment in Life … more
Strong Medicine? After Decades of Diluted Enforcement, FDA Issues Draft Guidance Announcing New Enforcement Policy for Homeopathic Drugs That Takes a Risk-Based Approach
by Stacy L. Ehrlich and Celeste D. Wheeler On December 18, 2017, the U.S. Food and Drug Administration (FDA) issued its long-awaited … more
New Least Burdensome Guidance
By Kinsey S. Reagan FDA today posted new draft guidance The Least Burdensome Provisions: Concept and Principles (December 15, 2017) addressing the … more
Stem Cell Therapy and the Practice of Medicine
By Kinsey S. Reagan Historically, FDA has stated in various contexts that it does not intend to regulate the practice of medicine. … more
Kleinfeld, Kaplan and Becker, LLP Recognized in “Best Law Firms” Rankings
We are pleased to announce that Kleinfeld, Kaplan and Becker, LLP has been recognized by U.S. News & World Report and Best … more
KKB Lawyers Recognized in 2018 Edition of “Best Lawyers in America”
We are proud to announce that Kleinfeld, Kaplan and Becker lawyers have been recognized in the latest edition of “Best Lawyers in … more
When A Device Maker Must Submit a 510(k)
Bloomberg BNA Publications published an article on September 13, 2017, indicating that FDA expects to meet the statutory timeline of November 8 … more
FDA’s New Plan for Tobacco and Nicotine Regulation
By Stacy L. Ehrlich On July 28, 2017, the new FDA Commissioner, Dr. Scott Gottlieb, announced a new comprehensive plan for tobacco … more