HHS reg­u­la­to­ry agen­da for 2021 is light on new pro­posed and fi­nal FDA rules

The im­pact of the coro­n­avirus on the FDA’s work plans is ev­i­dent in the lat­est se­mi-an­nu­al reg­u­la­to­ry agen­da for HHS, which in­cludes on­ly two new bio­phar­ma-re­lat­ed pro­posed rules and one fi­nal rule.

The two pro­posed rules cen­ter on one that seeks to change FDA med­ica­tion guide reg­u­la­tions and an­oth­er to clar­i­fy FDA’s study con­duct ex­pec­ta­tions for an­a­lyt­i­cal and clin­i­cal phar­ma­col­o­gy, bioavail­abil­i­ty (BA) and bioe­quiv­a­lence (BE) stud­ies.

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