Joe Biden, AP Images

Biden signs two bills to clar­i­fy new chem­i­cal en­ti­ties, ed­u­cate on biosim­i­lars

Pres­i­dent Joe Biden on Fri­day signed in­to law two FDA-re­lat­ed bills, in­clud­ing one to stop drug­mak­ers from win­ning ex­clu­siv­i­ty for drugs that aren’t re­al­ly new, and an­oth­er to add new ed­u­ca­tion­al ma­te­ri­als re­lat­ed to biosim­i­lars on­line.

The new law on new chem­i­cal en­ti­ties cod­i­fies the agency’s de­f­i­n­i­tion of an “ac­tive moi­ety” in the Food, Drug, and Cos­met­ic Act, pre­vi­ous­ly known as S. 415. The law re­solves any am­bi­gu­i­ty be­tween the FDA’s reg­u­la­tions and the statute, and makes clear that the de­f­i­n­i­tion of “ac­tive moi­ety” in FDA’s reg­u­la­tions should re­place what the law pre­vi­ous­ly de­scribed as an “ac­tive in­gre­di­ent (in­clud­ing any es­ter or salt of the ac­tive in­gre­di­ent).”

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