GAO of­fers 11 new poli­cies to im­prove re­gen­er­a­tive med­i­cine de­vel­op­ment in new re­port

Com­pa­nies that make re­gen­er­a­tive med­i­cines like CAR-T ther­a­pies, gene-edit­ed stem cells and eye im­plants face a num­ber of chal­lenges that lim­it the de­vel­op­ment and use of the ground­break­ing new treat­ments, a gov­ern­ment watch­dog said.

In a re­port made pub­lic on Thurs­day, the Gov­ern­ment Ac­count­abil­i­ty Of­fice said it has iden­ti­fied “mul­ti­ple chal­lenges” to de­vel­op­ing these types of ther­a­pies, in­clud­ing reg­u­la­to­ry un­cer­tain­ty as well as a lack of man­u­fac­tur­ing in­fra­struc­ture and in­dus­try stan­dards due to the evolv­ing and com­pli­cat­ed na­ture of the tech­nolo­gies.

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