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Revising its COVID-19 check coverage, the U.S. Meals and Drug Administration (FDA) stated Tuesday that the company would overview solely a small variety of new emergency use authorization (EUA) requests for diagnostic assessments.
As an alternative, the FDA urges builders searching for authorizations for his or her assessments to pursue the normal pathways for approval by way of the de novo classification or 510(ok) clearance. Nonetheless, the company will proceed to overview the presently pending EUA requests.
Noting that the company has issued EUAs for 430 COVID-19 assessments to this point, the FDA stated that these assessments present satisfactory testing capability all through the U.S.
Given the present degree of the manufacturing capability and shopper entry to assessments, “shifting to conventional premarket overview would greatest meet the general public well being wants on the present stage of the COVID-19 public well being emergency,” stated Jeff Shuren, director of the FDA’s Middle for Units and Radiological Well being.
Largest producers of speedy COVID-19 antigen assessments: Becton, Dickinson (BDX), Quidel (QDEL), Abbott Laboratories (NYSE:ABT), Roche (OTCQX:RHHBY) (OTCQX:RHHBF)
Different producers of speedy COVID-19 antigen assessments: QIAGEN (QGEN), OraSure Applied sciences (OSUR), LumiraDx (LMDX)
Producers of COVID-19 PCR assessments: Thermo Fisher Scientific (TMO), PerkinElmer (PKI), Bio-Rad Laboratories (BIO), Co-Diagnostics (CODX), Hologic (HOLX)
At dwelling COVID-19 PCR check makers: Cue Well being (HLTH)
Makers of COVID-19 antibody assessments: Laboratory Corp. of America (LH), Quest Diagnostics (DGX)
The revised coverage marks a shift within the FDA’s priorities because the COVID-19 influence wanes. Final month, the Biden administration introduced plans to transition the government-led procurement and distribution of COVID-19 vaccines and therapeutics to the business market.
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