The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities. The only exception is the cosmetic sector; registration [...]
The year 2020 started out ordinarily enough for the FDA Compliance Simplified team. We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices. On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.
Helping companies comply with FDA regulations is our specialty. But FDA is not the only regulatory body our clients need to be aware of. As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success [...]
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.
Near the end of 2017 FDA published test results from a gluten free food product surveillance project. By way of background, recall that in 2013 FDA published a final rule on gluten free labeling of foods, including dietary supplements. The rule, codified in 21 CFR [...]
On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]
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 [...]
In January we told you about some of FDA’s plans for 2011. The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review. Back in June FDA completed one agenda item, review of proposed [...]
The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]