FDA Compliance Simplified is privileged to help companies of all sizes and from all over the globe achieve compliance with FDA regulations. Many are referred to us by existing customers, some find us online, and other come to us through quality service providers that help [...]
Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Successful launch of a product requires more than a good marketing plan. It is also important to know whether your product is subject to special regulations from various government agencies. While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency [...]
I attended a meeting with FDA staff from the Denver District Office in November of 2014. The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society. Since most of the members work with medical devices, the [...]
Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19th warning letter to mention Facebook. Some of these letters from the past three years have also cited Twitter and Tumblr as sources of [...]
Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance. I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]
I hope that your business is doing well enough to allow you to relax a bit as summer starts. Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs [...]
The device industry in the US continues to wonder what will become of the 510(k) process. Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) [...]