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Originally published in Healthcare Michigan, Volume 41, No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more
Our Environment, Land Use & Natural Resources Group reviews the Environmental Protection Agency’s announcement of final amendments to the air toxics standards for ethylene oxide (EtO) commercial sterilizers....more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for drug development programs. The draft...more
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more
The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more
On October 22, 2021, the U.S. Food and Drug Administration (FDA) published an update on its efforts to assist US companies on China’s implementation of a new registration requirement for all food facilities importing foods...more
The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more
The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more
Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more
The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more
CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more
The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more
Lately, products containing CBD (from beer to skin cream to oils that can be diffused and vaped) seem to be all the rage. Why are CBD products suddenly turning up everywhere (your local Sheetz convenience store for...more
The U.S. Food and Drug Administration (FDA) announced that it is reopening the comment period on a 2005 proposed rule to establish a set of general principles to use when considering whether to establish, revise, or eliminate...more
Manufacturers, distributors, and suppliers of CBD products should embrace and participate in reform to address public health concerns, write Bilzin Sumberg attorneys. Consumer groups like the Arthritis Foundation are stepping...more
A class action lawsuit alleging that Green Roads of Florida LLC misrepresented the amount of CBD contained in various products has been stayed pursuant to the primary jurisdiction doctrine because the plaintiffs’ claims...more
With the rise of plant-based alternatives to conventional meat products, the industry has come under scrutiny from government regulators, both in the United States and abroad. In 2019 alone, nearly 30 states considered...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more