The FDA’s back­log of drug man­u­fac­tur­ing fa­cil­i­ty in­spec­tions con­tin­ues to be a sore spot for the agency, as FDA said Mon­day that a to­tal of 52 new drug (but no bi­o­log­ics) ap­pli­ca­tions still re­main de­layed due to the back­log from the pan­dem­ic.

And while the agency has main­tained that it won’t is­sue a CRL for a de­layed in­spec­tion, the num­ber of de­layed ap­pli­ca­tions is ris­ing as FDA said in May that 48 new drug ap­pli­ca­tions have been de­layed due to FDA’s in­abil­i­ty to con­duct pre-ap­proval, pre-mar­ket, or pre-li­cense in­spec­tions as of last March.

The agency’s in­abil­i­ty to work over­seas has al­so hurt its out­put well in­to 2021, with just 37 for­eign drug in­spec­tions be­tween April and Sep­tem­ber 2021. Pri­or to the pan­dem­ic, the FDA typ­i­cal­ly con­duct­ed about 1,000 for­eign drug in­spec­tions per year.

“FDA be­gan the new fis­cal year with on­go­ing trav­el re­stric­tions and oth­er un­cer­tain­ties con­tin­u­ing to im­pact over­sight op­er­a­tions. FDA is con­tin­u­ing to com­plete mis­sion-crit­i­cal work, pri­or­i­tize oth­er high­er-tiered in­spec­tion­al needs (e.g., for-cause in­spec­tions), and car­ry out sur­veil­lance in­spec­tions us­ing risk-based ap­proach­es for eval­u­at­ing pub­lic health im­pact,” FDA said in its new re­port.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

“As we have done through­out the pan­dem­ic, FDA will use every op­tion avail­able to meet our reg­u­la­to­ry re­spon­si­bil­i­ties and pro­tect the pub­lic health, in­clud­ing con­tin­ued col­lab­o­ra­tion with state, lo­cal, trib­al, ter­ri­to­r­i­al, and for­eign reg­u­la­to­ry part­ners,” the agency added.

De­spite the back­log, there were a few bright spots in the re­port too.

In ear­ly 2021, the FDA es­ti­mat­ed that more than 15,000 sur­veil­lance in­spec­tions through­out the US had been post­poned thanks to the Covid-19 pan­dem­ic. The agency pre­dict­ed that it would com­plete 14% of those in­spec­tions, in­clud­ing 26% of the re­main­ing hu­man and an­i­mal med­ical do­mes­tic sur­veil­lance in­spec­tions. The agency ex­ceed­ed that num­ber two-fold, it re­port­ed, a com­ple­tion rat­ing of 134%.

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.