Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
In a new FDA Voices, titled FDA maintains the pace of meeting its goals on applications for medical products during the pandemic, FDA Commissioner Stephen M. Hahn, M.D., explains that one of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.
The FDA is partnering with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug Repurposing Collaboratory (CDRC). CDRC is a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches warranting further study.
A Consumer Update, titled Getting Smarter about Food Safety: The Pandemic and Lessons Learned, explains that throughout the COVID-19 pandemic, the experts at the FDA have learned valuable lessons that will help shape our work to create a more digital and transparent, as well as safer, food system for you and your family. In the coming weeks, the FDA will unveil the blueprint for the New Era of Smarter Food Safety, which lays out how we will use technology and modern approaches over the next decade to strengthen the ways we approach the safety of the nation’s food supply, every day and in times of crisis.
To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.