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.
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.
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 [...]
In August of last year, we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that [...]
The most amusing title I have ever seen on an FDA guidance document is “Is it a Cosmetic, a Drug or Both? (Or is it soap?)” http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. This guidance addresses common misconceptions about how certain products are regulated. Hand sanitizers and antibacterial soaps are examples [...]