HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More

A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More

CDER Director Janet Woodcock told lawmakers the FDA’s current medical information system is outmoded and the agency is developing the Patient Medication Information (PMI) document — a single, standardized medication information leaflet — to fix it. Read More

Merck Monday offered to pay out $27.7 million to settle nearly 1,200 personal injury lawsuits claiming its osteoporosis drug Fosamax caused jaw-bone deterioration known as osteonecrosis of the jaw (ONJ). Read More

The FDA stands by its allegation that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More

The FDA has approved Gilead’s hepatitis C drug sofosbuvir, which received a unanimous recommendation from agency advisors. Read More

Prosecutors appear ready to lean more heavily on the False Claims Act in prosecuting off-label marketing cases, sidestepping a ruling in the U.S. Second Circuit that found off-label promotion was protected free speech and not prosecutable under the 1938 FD&C Act. Read More

The FDA’s unusual demand that an importer of active pharmaceutical ingredients (API) list the distributors that might sell finished product created with the API has sparked a lawsuit that could further complicate U.S. border control processes. Read More

The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More

Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals is appealing to the courts to keep Gilead’s competing hepatitis C treatment off pharmacy shelves. Read More

The FDA wants Wockhardt to investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift an import ban it slapped on the plant Nov. 26. Read More