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…

Federal right-to-try legislation passed in the Senate and now awaiting a vote in the House would only minimally benefit patient access to investigational drugs and would delay the FDA’s approval…

The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany. Source: Drug…

A Michigan clinic manager pleaded guilty to a scheme to unnecessarily prescribe controlled substances that lost Medicare $131 million, and Attorney General Jeff Sessions called the plea the latest victory…