The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
The U.S. FDA held a July 7 webinar to go over a recent guidance on decontamination and bioburden reduction of N95 masks for the COVID-19 pandemic, and one of the take-away messages is that the agency is still quite concerned about the impact of residues left over from those processes, given that some of these residues can be inhaled by the wearer and trigger health problems of their own.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
Rear Admiral John Polowczyk, vice director of logistics for the Joint Chiefs of Staff, said in a Senate hearing that the one solution to managing pandemic supplies might be to use federal taxpayer dollars to sustain inventories in private-sector warehouses.
Armonk, N.Y.-based International Business Machines Corp. (IBM) launched the Rapid Supplier Connect network to help government agencies and health care organizations tap into new, non-traditional suppliers now producing devices and equipment needed to battle COVID-19. Membership in the blockchain-based network is free through Aug. 31, 2020, to qualified participants.
The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
TORONTO – Canadian Prime Minister Justin Trudeau has yet to rule out following U.S. President Donald Trump’s lead by invoking his nation's wartime Defense Procurement Act compelling manufacturers to begin making ventilators to combat COVID-19. For now, Ottawa has signed contracts or letters of intent with eight equipment makers.
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.