The EPA Non-PRIA Notification Close Out Has Arrived
Effective June 28, 2023, all antimicrobial notifications submitted to the Antimicrobials Division (AD) prior to October 1, 2022 have been closed out by the Environmental Protection Agency (EPA). The Agency announcement, released on June 29, [...]
EPA Triggers Emerging Viral Pathogens Policy for Marburg Virus
In response to recent simultaneous outbreaks of Marburg virus in Tanzania and Equatorial Guinea the United States EPA has engaged the Emerging viral Pathogens Policy (EVP). The Ministry of Health and Social Welfare for Equatorial [...]
Let’s Get Ready for MoCRA!
What is MoCRA? The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 was signed into law by President Biden on December 29, 2022 as part of the 2023 Consolidated Appropriations Act , H.R. 2617. This [...]
California Legislation for Cosmetic Products
In addition to compliance assistance with the new Food & Drug Administration (FDA) Modernization of Cosmetics Regulation Act (MoCRA) of 2022, SRC offers compliance support for cosmetic ingredient disclosure and reporting requirements for the California Safe [...]
FDA 2023 OMUFA Fees
On March 24, 2023, the US Food and Drug Administration (FDA) announced its 2023 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The Monograph Drug Facility (MDF) fee [...]
FDA Warning Letter Trends for Over-The-Counter Drugs
SRC monitors industry trends through frequent communication with regulating agencies, and review of warning letters and enforcement actions. From our monitoring of FDA Warning Letters, we have noticed some recent trends in FDA enforcement and [...]