FDA Withdraws Compliance Policy Guide on Homeopathic Drug Products and Issues Revised Draft Guidance
By: Suzan Onel and Justine E. Lenehan November 5, 2019 On October 24, 2019, the U.S. Food and Drug Administration (FDA) announced … more
By: Suzan Onel and Justine E. Lenehan November 5, 2019 On October 24, 2019, the U.S. Food and Drug Administration (FDA) announced … more
By: Suzan Onel On Tuesday, October 29, 2019, the United States Department of Agriculture (“USDA”) issued a pre-publication copy of its interim … more
By: Daniel Logan and Stacy Ehrlich Introduction On September 25, 2019, the Food and Drug Administration (FDA) published in the Federal Register … more
By Stacy Ehrlich & Will Woodlee On March 13, 2019, FDA published a Draft Guidance entitled “Modifications to Compliance Policy for Certain … more
By Stacy Ehrlich FDA will publish a proposed rule in the Federal Register on Tuesday, February 26, 2019, that, when finalized, would … more
By: Kinsey S. Reagan On February 15, 2019, FDA issued two final guidance documents for regenerative medicine advanced therapy (RMAT) products (Evaluation … more
By Will Woodlee On February 11, 2019, FDA announced an intention to bring greater control to the dietary supplement marketplace. Twenty-five years … more
KKB Partner Suzan Onel will be speaking at the ACI’s Cosmetics & Personal Care Products – Legal, Regulatory and Compliance Conference, being … more
Kleinfeld, Kaplan & Becker, LLP, is pleased to announce the election of Cynthia L. Meyer as a partner in the firm, effective … more
The Practicing Law Institute (PLI) recently published the 6th edition of its Medical Devices Law and Regulation Answer Book for 2019. KKB … more