FDA Withdrawal of Temporary COVID-19 Pandemic Hand Sanitizer Manufacturing Guidelines; Additional Testing May Be Required
Published In: American Pharmaceutical Review
Jan/Feb Edition 2022
On October 12, 2021 the FDA’s Center for Drug Evaluation and Research (CDER) released a notification stating that on December 31st, 2021, it intends to withdraw the three guidance documents regarding temporary policies for production/preparation of ABHRs due to the observation that supply of hand sanitizers by traditional drug manufacturers now meets demand. In order to provide time for manufacturers to respond to the removal of these temporary policies, companies had to halt manufacturing by no later than December 31, 2021. Click below to read the full article.
Addressing the Ongoing Risks of C. Diff in Healthcare Settings
Published In: MDDI Online
December 7, 2021
The bacterium Clostridioides difficile, which was formerly named Clostridium difficile and is now commonly known as C. difficile or simply C. diff, is a common microorganism found in the environment. In general, it doesn’t raise serious concerns for healthy individuals. However, some individuals who are taking antibiotics, particularly for long periods of time, experience disturbances in their normal balanced gut flora (microbiota) due to the antibiotics’ inadvertent killing of protective bacteria. This disruption can affect important immunoregulatory and metabolic functions, turning a relatively unnoticed organism into a harmful pathogen, raising serious healthcare concerns.
Testing the Safety and Efficacy of Multifunctional Personal Care Products, A Primer
Published In: Cosmetic and Toiletries
April 21, 2022
Multifunctional products, such as hand sanitizers with moisturizing claims, are becoming more popular as increased use of hand disinfectants continues to rise. Learn what additional testing considerations are required when looking to introduce multifunctional products to market in our new Cosmetic and Toiletries article.