Washington Drug Letter

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.

The FDA appears poised to require clinical trial data from drugmakers seeking biosimilar interchangeability designations, a move that could shrink the number of products that aim to achieve the standard, drugmakers and legal experts say.

Drug manufacturers should prepare to use the updated version of Module 1 of the electronic common technical document (eCTD) by September of next year, even though it will likely remain optional until 2015, FDA officials advise.

Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials.

The FDA is working with Boehringer Ingelheim to look into a possible increased risk of heart failure with Mirapex, a Parkinson’s disease and restless leg syndrome drug.

The House late Wednesday passed a fix that would allow the FDA to begin collecting the generic user fees authorized by the FDA Safety and Innovation Act.

Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.

A district court judge has largely sided with Jazz Pharmaceuticals’ definitions for patents on its narcolepsy drug Xyrem, and the outcome looks like a “clear win” in Jazz’s legal struggle to prevent generic competition from Roxane Laboratories, one analyst says.

Janssen Biotech has submitted a BLA seeking approval of an IV formulation of Simponi to treat adults with moderate to severe rheumatoid arthritis (RA).

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure.