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Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive...
More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the...
The US agency continues to keep a watchful eye over the nation’s pandemic response, issuing advice to professionals and taking action where appropriate. According to NPR, as of this week, 246m doses of the various vaccines against COVID-19 have been distributed in the US. More than 105m Americans have been fully vaccinated, or nearly 32% of the total population. However, the pandemic is far from over, and US Food and Drug Administration (FDA) measures to monitor treatments and vaccines, watch out for fraudulent products, advise life-sciences professionals on d...
FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities By Mark Durivage, Quality Systems Compliance LLC On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency, to address the coronavirus disease 2019 (COVID-19) public health emergency. This guidance was implemented without prior public comment because the FDA determined that prior public participation was not feasible or appropriate. However, public comments may be submitted at any time...
Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More > Arbitr...