On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
On February 18, 2021, Acting FDA Commissioner Janet Woodcock and Acting USDA Secretary Kevin Shea issued a joint COVID-19 update statement that current epidemiologic and scientific information available to the FDA and USDA...more
As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their...more
The U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) (collectively, the “Agencies”) have a long history of teaming up to ensure that advertising and other promotional communications for...more
The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
Today the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for...more
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more
Today the federal bank regulatory agencies issued joint guidance on Providing Financial Services to Customers Engaged in Hemp-Related Businesses (Joint Hemp Guidance). These agencies – the Office of the Comptroller of the...more
Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more