Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
The consumer-packaged goods and restaurant industries play a crucial role in the global food supply chain, providing a wide variety of food options that consumers rely on for their daily nourishment. However, the integrity of...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more