FDA Deferment On Alcohol Based Handrub Products To End Dec. 31

On October 12, 2021 the FDA’s Center for Drug Evaluation and Research (CDER) released a notification that it intends to withdraw the three guidance documents regarding temporary policies for production / preparation of Alcohol Based Handrub Products due to the observation that supply of hand sanitizers by traditional drug manufacturers now meets demand. The FDA has stated that these guidance documents are intended to be withdrawn on December 31, 2021. Manufacturers that entered the hand sanitizer market during the pandemic, and took advantage of deferred testing requirements, must meet the FDA regulatory guidelines if they wish to continue sales of these products past the deadline.

BioScience Laboratories hosts a team of experts with years of clinical testing experience for personal and healthcare antiseptic products. Talk to one of our experts today to get your clinical efficacy study underway.

SARS-COV-2 - Topical Disinfectant Efficacy Testing

Looking to add claims against Covid-19 to your marketing or product label? We can help you get the necessary data for product registration and additional marketing and label claims. Our Biosafety Level - 3 laboratory allows us to offer efficacy testing directly against SARS-COV-2. Speak to one of our experts today.

Clinical Studies - Coronavirus Efficacy Testing

Our dedicated laboratory and recruitment teams are ready get you the clinical testing data you need on the timeline you want.

Custom Study Design - Get The Exact Data You Need

Our experts are on stand by to discuss the design of your next study. Both standardized and custom protocol development available.