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Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more
The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more
In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more
The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more
Even as states across the country move forward with legislation and state plans for legalized industrial hemp and hemp-derived products, the news coming out of Washington, DC has slowed. This does not mean that regulatory...more
The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019...more
The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency....more
Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more