Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the ma­jor­i­ty of drug short­ages are still as­so­ci­at­ed with man­u­fac­tur­ing-re­lat­ed qual­i­ty is­sues, the FDA on Thurs­day pub­lished new draft guid­ance spelling out how to proac­tive­ly as­sess risks to man­u­fac­tur­ing process­es and sup­ply chains, while un­der­stand­ing the mar­ket’s vul­ner­a­bil­i­ties.

While drug short­ages peaked in 2011, the FDA says in its new 18-page draft guid­ance that the num­ber of new drug short­ages “has de­clined sig­nif­i­cant­ly since” that peak, reach­ing a low in 2015 and 2016, thanks in part to a new law’s en­act­ment, known as FDA­SIA, which helped the agency bet­ter pre­vent or mit­i­gate drug sup­ply dis­rup­tions and short­ages, and clar­i­fied cGMP re­quire­ments.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.