FDA increases oversight and toughened its requirements for coronavirus antibody tests.
Since mid-March, the FDA has let manufacturers distribute unauthorized antibody tests, provided they validate the tests themselves and do not advertise them as a standalone method of diagnosing a patient. Instead, they could be used to track the spread of the virus through the population, by detecting signs of an immune response to a previous infection.
Questions have mounted in recent weeks about the accuracy of serological testing currently available that have not received agency review and emergency use authorization.
Now, under a revised policy, manufacturers must submit an Emergency Use Authorization (EUA) request with their validation data within 10 business days from the date they notified the FDA of their validation testing, or from the May 4 issuance of the policy — whichever is later.
FDA misses (third time) internal April 2020 deadline for publishing a draft of its revised Quality System Regulation.
The US Food and Drug Administration has missed yet another internal deadline for publishing a draft of its retooled Quality System Regulation. The agency has been working on harmonizing its QSR with international quality systems standard ISO 13485 since mid-2018.
The QSR has been the bedrock rule for manufacturing safe and effective medical devices to be sold in the US since the late 1990s, while ISO 13485:2016 is used by device firms to ensure quality systems compliance with regulators in a variety of countries.
A joint alert from the U.S. Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and the United Kingdom’s National Cyber Security Centre (NCSC) was released May 5, 2020 containing information on continued exploitation by advanced persistent threat (APT)* groups of the current coronavirus disease 2019 (COVID-19) global pandemic. It includes information describing the methods these actors are using to target organizations and provides mitigation advice.
According to the agencies, APT actors are actively targeting organizations involved in both national and international COVID-19 responses. These organizations include healthcare bodies, pharmaceutical companies, academia, medical research organizations, and local government. APT actors frequently target organizations in order to collect bulk personal information, intellectual property and intelligence that aligns with national priorities, say the agencies.
Some risk mitigation practices both agencies recommend are:
*An advanced persistent threat is a stealthy computer network threat actor, typically a nation state or state-sponsored group, which gains unauthorized access to a computer network and remains undetected for an extended period.Quality / Compliance / Regulatory Updates – 15 May 2020
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