Califf cau­tions against low­er­ing FDA stan­dards; Ed­i­tas out­lines $1B mile­stone pack­age

→ Ex-FDA Com­mis­sion­er Robert Califf is back at Duke. And he has some ad­vice for the Trump ad­min­is­tra­tion as it fol­lows through on plans to re­or­ga­nize the agency and cut re­view times. “Short­en­ing and ex­pe­dit­ing is a great idea, but it needs to be done with­out low­er­ing the stan­dards,” Califf told Duke’s The Chron­i­cle. In the stu­dent news­pa­per, Califf point­ed out that more than 90 per­cent of drugs en­ter­ing clin­i­cal tri­als cur­rent­ly do not make it to the mar­ket. If reg­u­la­tions are loos­ened to ap­prove those, he said “a lot of peo­ple are go­ing to get hurt or end up tak­ing in­ef­fec­tive drugs.”

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