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Latest FDA COVID-19 related advice and actions

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 dealing with restrictions, and issue (or revoke) emergency use authorizations (EUAs) continues. Here are the latest actions and advice from the agency. ....

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FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities

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 for agency consideration.
During the COVID-19 public health emergency, the FDA is limiting unnecessary contact by only conducting prioritized domestic facility inspections and those that are deemed mission-critical. For unprioritized inspections, non-mission-critical domestic inspections, and inspections impacted by travel restrictions resulting from the public health emergen ....

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AGG Food & Drug Newsletter - April 2021 | Arnall Golden Gregory LLP

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 >
Arbitration as an Alternative to the Backlogged Courts ....

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Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding
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COVID-19 Medical Products Supply Chain Week in Review – April 2021 #3 | Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #3 | Alston & Bird
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