FDA Guidance Takes Drugmakers to Task on Postmarket Studies

A drug manufacturer’s failure to adequately recruit clinical trial subjects won’t be considered a legitimate reason for failing to fulfill FDA postmarketing study requirements, according to draft guidance released Thursday.

The document, which includes nonbinding recommendations for industry, outlines how a drugmaker must demonstrate “good cause” for failing to submit study protocols in time or fulfill other commitments that the Food and Drug Administration may require for certain drugs.

The Federal Food, Drug, and Cosmetic Act allows the FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if ...