Cit­i­zen pe­ti­tions: FDA re­vis­es guid­ance to block drug­mak­ers from abus­ing the sys­tem

The FDA on Tues­day is­sued a re­vised draft guid­ance de­signed to al­low for the FDA to re­ject 505(q) pe­ti­tions if the agency de­ter­mines the pri­ma­ry pur­pose of the pe­ti­tion is to de­lay the ap­proval of an ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA).

“We be­lieve this will pro­vide an ad­di­tion­al de­ter­rent to pur­su­ing these tac­tics,” the FDA said.

The new ap­proach to re­view­ing pe­ti­tions would al­so help the FDA fo­cus its re­sources on ad­dress­ing pe­ti­tions that are most like­ly to present an ob­sta­cle to the avail­abil­i­ty of gener­ic drugs.

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