On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and [...]
In January 2020, EPA responded quickly to the COVID-19 pandemic by triggering its Emerging Viral Pathogens Guidance allowing registrants who provide data against a harder to kill virus to make marketing claims against the SARS-CoV-2. Shortly after, EPA created List N: Disinfectants for Use Against SARS-CoV-2 to assist consumers with finding products effective against the virus. [...]
At Scientific & Regulatory Consultants, Inc. (SRC), our mission is to create a better world through antimicrobial and pesticide use, innovation, and compliance. This mission became more important than ever, in 2020, during the COVID-19 pandemic. SRC has continued our focus on helping drive change and showing our appreciation for our local community and industry [...]
We are excited to announce that in 2021 Scientific & Regulatory Consultants, Inc. (SRC) will celebrate its 25th Anniversary as a full-service regulatory consulting firm! SRC began in 1996, when Sally Hayes and Rhonda Jones brought together their unique expertise in microbiology, chemistry, and toxicology as well as their collaborative experience with government entities to [...]
On July 07, 2020, EPA released a new guidance expediting review of label amendments for List N products adding electrostatic spray (ESS) application to the Directions for Use. Under this guidance EPA will try to reduce Pesticide Registration Improvement Act (PRIA) review timelines by 1-2 months. SRC received additional guidance from EPA on July 24, [...]
Upon the outbreak of Coronavirus Disease 2019 (COVID-19), consumers were instructed by the Centers for Disease Control and Prevention (CDC) to protect themselves and their families by washing their hands with soap and water for at least 20 seconds or utilizing a hand sanitizer containing at least 60% alcohol when handwashing is not available. CDC [...]
What You Need to Know: On March 20, 2020 (updated on April 15, 2020), FDA issued a temporary policy for the manufacturing of alcohol-based hand sanitizers during the COVID-19 public health emergency. This temporary guidance only applies to the manufacture of hand sanitizers that use alcohol (ethanol) or isopropanol as the active ingredient. The following [...]
In response to the COVID-19 pandemic, caused by a novel coronavirus SARS-CoV-2, the US EPA has announced certain streamlined processes for some disinfectant products. It is important to understand whether your product qualifies for any of these pathways, and what the associated requirements are. New Registrations Does a new disinfectant or antimicrobial product qualify for [...]
COVID-19 Testing SRC has approval from EPA to conduct disinfectant testing on the SARS-CoV-2 (COVID-19 outbreak strain) through Microbac Laboratories’ BSL-3 facility. Dr. Steve Zhou and his amazing team have nearly completed all propagation and feasibility studies. Please contact SRC to secure scheduling to prove effectiveness of your product, and assistance expediting the federal and [...]