The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
April 26, 2024 Dear Colleague,
While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.
A Milestone in Facilitating the Development of Safe and Effective Biosimilars By: Sarah Yim, M.D., Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., Chief Medical Officer and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created a pathway for the U.S. Food and Drug Administration to approve biosimilars. A biosimilar is a biological product (biologic) that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic (also called the reference product). Biologics are some of the most expensive treatments in the U.S., and approving biosimilars can enhance competition, drive down costs to health care systems, and increase patient access to biologic therapies.
Reflections on Travel to Europe – Part Two By: Robert M. Califf, M.D., Commissioner of Food and Drugs
Our first stop on our recent European trip was London. Although the jet lag on the first day after crossing the Atlantic can be tough and the second day is often more trying, the trip was invigorating and thought provoking. The U.S. Food and Drug Administration’s Office of Global Policy and Strategy and Office of Commissioner staff did a great job arranging a busy schedule that covered multiple critical topics. We had an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response.
This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants.
This revised draft guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k)).
The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, June 4, 2024, to answer stakeholder questions regarding the chemistry, manufacturing, and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products. Experts from OTP’s Office of Gene Therapy CMC will be on hand to answer questions.
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.
April 26, 2024
Our first stop on our recent European trip was London. Although the jet lag on the first day after crossing the Atlantic can be tough and the second day is often more trying, the trip was invigorating and thought provoking. The U.S. Food and Drug Administration’s Office of Global Policy and Strategy and Office of Commissioner staff did a great job arranging a busy schedule that covered multiple critical topics. We had an initial dinner with an eclectic group from the U.K. dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response.