FDA+ roundup: Spring reg­u­la­to­ry agen­da looks to fin­ish off Cures im­ple­men­ta­tion; GAO digs in­to med­ical coun­ter­mea­sures

The Biden ad­min­is­tra­tion re­leased its Spring reg­u­la­to­ry agen­da, of­fer­ing up plans on which pro­posed and fi­nal rule­mak­ings will be com­ing down the pike in the not-too-dis­tant fu­ture.

For the FDA, many of the draft and fi­nal rules are re­peats, al­though the agency will look to clear its plate of re­main­ing 21st Cen­tu­ry Cures Act oblig­a­tions, which have been in the works since 2016.

For in­stance, al­though Sec­tion 3023 of the Cures Act has a Dec. 2019 statu­to­ry dead­line, the agen­da shows the FDA is still hop­ing to re­lease two pro­posed rules re­lat­ed to that part of the bill this Sep­tem­ber.

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