The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created…

The federal government’s guidance for monitoring opioid use among Medicare beneficiaries does not go far enough in identifying which beneficiaries are most at risk and the Centers for Medicare &…

Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday. Source: Drug…

The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to…

The parents of twin girls with a rare genetic disorder sued a drugmaker and therapy accelerator for misappropriating the children’s trial data to secure a breakthrough therapy designation. Source: Drug…

The GAO called on the FDA to make its plans for publishing and revising guidance for nonbiological complex drugs (NBCDs) public, noting that sudden guidance changes cause a major expense…

The FDA and the Department of Defense announced a joint program Tuesday to prioritize development of medical products for deployed military personnel. Source: Drug Industry Daily

The FDA will delay implementing “intended use” sections of a final rule while reassessing language that industry groups said could cause confusion. Source: Drug Industry Daily

The FDA will begin publishing information from sponsor-produced clinical study reports, starting with documents volunteered by companies following a drug’s approval, as part of a broader agency effort to boost…

The FDA approved 78 generic drugs last month, an increase from 56 the previous December — including six first-time approvals. Source: Drug Industry Daily