The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to shortages and should be subject to risk management plan (RMP) reporting. The guidance also recommends risk factors to consider when developing the content of the RMPs.
Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), FDA was given new authorities to collect information from manufacturers in responding to pandemic-prompted shortages. The law added a new section 506C(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) requiring certain manufacturers to develop and implement a “redundancy risk management plan” to evaluate the potential for drug shortages…
