On December 23, 2019, the U.S. Food and Drug Administration (FDA) published in the Federal Register a set of proposed rules covering the requirements and procedures for importing under Section 804 of the federal Food, Drug, and Cosmetic Act (FDCA) prescription drugs from Canada. It is these proposed rules under which prescription drugs intended for … Continue Reading
By Rachael G. Pontikes, Emily L. Hussey, Kelly Kearney and Allyson Wilson on Posted in Regulatory Developments
On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities conducted in accordance with Section 503A of the Federal Food, Drug, & Cosmetic Act (FDCA). With this … Continue Reading
By Rachael G. Pontikes, Emily L. Hussey and Kelly Kearney on Posted in Regulatory Developments
On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of Columbia’s ruling related to the United States Food & Drug Administration’s (FDA) placement of Vasopressin on the Agency’s “clinical need” list. As may be recalled from our previous alert, Athenex sued FDA … Continue Reading
Just as the U.S. Food & Drug Administration (“FDA”) promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register in the past week related to bulk drug substances that can be compounded subject to the conditions of Section 503A and Section 503B of the Federal Food, Drug, … Continue Reading
The Food and Drug Administration (FDA) will hold a public hearing on May 31, 2019, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 This offers those within the cannabis industry a unique opportunity to speak on their concerns and interests … Continue Reading
On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading
