CDER lays out 2021 guid­ance agen­da

The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) re­leased a list of the new and re­vised draft guid­ances it plans to re­lease in 2021.

The agen­da, while of­ten­times as­pi­ra­tional, pro­vides in­sights as to what the agency’s drug cen­ter’s new guid­ance pri­or­i­ties are for the com­ing year. How­ev­er, the list does not in­clude draft or re­vised guid­ances the agency plans to fi­nal­ize in 2021.

Many of the planned guid­ances on the list were in­clud­ed in pre­vi­ous years’ agen­das, such as the pro­posed clin­i­cal phar­ma­col­o­gy draft guid­ance “As­sess­ing the Ef­fects of Food on Drugs in INDs or NDAs – Gen­er­al Con­sid­er­a­tions,” and up­dat­ed guid­ance on “Phar­ma­coge­nom­ic Da­ta Sub­mis­sion” and “Phar­ma­co­ki­net­ics in Pa­tients with Im­paired Re­nal Func­tion – Study De­sign, Da­ta Analy­sis and Im­pact on Dos­ing and La­bel­ing.”

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