The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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
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
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
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More