The FDA wants to know what peo­ple think about the use of AI in the phar­ma man­u­fac­tur­ing space.

Ac­cord­ing to a pub­lic in­spec­tion doc­u­ment, the FDA plans to pub­lish a re­quest for in­for­ma­tion no­tice on Wednes­day, aim­ing to gath­er pub­lic com­ments on “emerg­ing and ad­vanced” man­u­fac­tur­ing tech, specif­i­cal­ly in ar­ti­fi­cial in­tel­li­gence’s use in phar­ma man­u­fac­tur­ing.

The pa­per will lay out “ar­eas for con­sid­er­a­tions and pol­i­cy de­vel­op­ment” from the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) sur­round­ing AI in phar­ma­ceu­ti­cal man­u­fac­tur­ing. The pa­per is meant to en­cour­age and gath­er feed­back from the pub­lic, peo­ple in the in­dus­try, as well as CDER and the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER).

The doc­u­ment al­so says:

This dis­cus­sion pa­per presents ar­eas as­so­ci­at­ed with the ap­pli­ca­tion of AI to phar­ma­ceu­ti­cal man­u­fac­tur­ing that FDA has iden­ti­fied for con­sid­er­a­tion as FDA eval­u­ates our ex­ist­ing risk-based reg­u­la­to­ry frame­work. CDER sci­en­tif­ic and pol­i­cy ex­perts iden­ti­fied these ar­eas from a com­pre­hen­sive analy­sis of ex­ist­ing reg­u­la­to­ry re­quire­ments ap­plic­a­ble to the ap­proval of drugs man­u­fac­tured us­ing AI tech­nolo­gies.

Some ar­eas the FDA is hop­ing to re­ceive com­men­tary around in­clude any pos­si­ble dif­fi­cul­ties that may come about in ap­ply­ing cur­rent reg­u­la­tions to AI or any is­sues sur­round­ing a lack of guid­ance or ex­pe­ri­ence.

The dis­cus­sion pa­per was re­leased on Wednes­day and cov­ered sev­er­al sub­jects re­lat­ed to AI in man­u­fac­tur­ing. This in­clud­ed cloud ap­pli­ca­tions for da­ta, wether more clar­i­ty is need­ed about how AI is sub­ject­ed to reg­u­la­to­ry over­sight and the need for val­i­dat­ing AI mod­els.

The FDA has al­ready pro­duced some guid­ance in the use of new tech­nolo­gies or tech­niques in the phar­ma man­u­fac­tur­ing process. In 2014, CDER cre­at­ed the Emerg­ing Tech­nol­o­gy Pro­gram, or ETP, to work with com­pa­nies that were start­ing to use more ad­vanced man­u­fac­tur­ing tech­niques and over­all tech­nol­o­gy.

While no guid­ance spe­cif­ic to AI use in phar­ma man­u­fac­tur­ing has been de­vel­oped yet, there has been guid­ance sur­round­ing the prop­er use of ma­chine learn­ing and AI in med­ical de­vice de­vel­op­ment in 2021, as well as oth­er guid­ance sur­round­ing AI in de­vices. The FDA does have oth­er guid­ances for ad­vanced man­u­fac­tur­ing, main­ly cen­tered around con­tin­u­ous man­u­fac­tur­ing. A dis­cus­sion pa­per was al­so writ­ten last year on point-of-care man­u­fac­tur­ing.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed with more in­for­ma­tion from the dis­cus­sion pa­per re­leased by the FDA. 

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.