Risk Management Plans To Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Risk Management Plans to Mitigate the Potential for Drug Shortages." This draft guidance is intended to help stakeholders develop, maintain, and implement, as appropriate, risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. In March 2020, with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended to require certain manufacturers to develop, maintain, and implement, as appropriate, a "redundancy risk management plan." This draft guidance provides information about the development and content of RMPs for those manufacturers as well as for other stakeholders. This draft guidance recommends a framework and factors to consider that stakeholders can use to develop RMPs. This draft guidance is relevant for all stakeholders, including those with oversight and control responsibilities for drug quality and contract establishments, and for manufacturers of active pharmaceutical ingredients (APIs), approved or licensed drug and biological products, and drug products marketed without an application.