EMA, FDA and WHO prep for new coro­n­avirus treat­ments, IVDs

Fol­low­ing the World Health Or­ga­ni­za­tion’s (WHO) de­ter­mi­na­tion last week that the spread of the nov­el coro­n­avirus (2019-nCoV) from Wuhan, Chi­na is a pub­lic health emer­gency of in­ter­na­tion­al con­cern, the Eu­ro­pean Med­i­cines Agency (EMA), FDA and WHO have tak­en var­i­ous pre­cau­tions and pre­pared for new med­i­cines, vac­cines and in vit­ro di­ag­nos­tics (IVDs).

FDA on Tues­day is­sued an Emer­gency Use Au­tho­riza­tion (EUA) to au­tho­rize the emer­gency use of Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s (CDC) 2019-Nov­el Coro­n­avirus (2019-nCoV) Re­al-Time Re­verse Tran­scrip­tase (RT)-PCR Di­ag­nos­tic Pan­el for the “pre­sump­tive qual­i­ta­tive de­tec­tion of nu­cle­ic acid from the 2019-nCoV in up­per and low­er res­pi­ra­to­ry spec­i­mens (such as na­sopha­ryn­geal or oropha­ryn­geal swabs, spu­tum, low­er res­pi­ra­to­ry tract as­pi­rates, bron­choalve­o­lar lavage, and na­sopha­ryn­geal wash/as­pi­rate or nasal as­pi­rate) col­lect­ed from in­di­vid­u­als who meet CDC cri­te­ria for 2019-nCoV test­ing.”

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