BioCentury
ARTICLE | Clinical News

Zeftera ceftobiprole regulatory update

August 24, 2009 7:00 AM UTC

FDA issued a warning letter to Johnson & Johnson in which the agency concluded the company had not adhered to applicable requirements and regulations related to the conduct of clinical trials of ceftobiprole to treat complicated skin and skin structure infections (cSSSIs). Basilea, which granted J&J worldwide rights to the product, said the letter relates to observations from FDA inspections conducted in early 2008. Specifically, the agency noted deficient recordkeeping and drug accountability as a result of failure to ensure proper monitoring of the clinical investigations, failure to ensure that studies were conducted in accordance with IND-specified protocols and applicable FDA regulations, and failure to ensure the selection of qualified investigators. J&J has 15 days from receipt of the Aug. 10 letter to notify FDA of an action plan for preventing similar violations in the future.

Last year, J&J received a complete response letter from FDA for ceftobiprole to treat cSSSIs, including diabetic foot infections, in which FDA said further resolution of "deficiencies of study conduct" was necessary (see BioCentury, Dec. 8, 2008). In April, EMEA delayed its decision on an MAA for the product to treat complicated skin and soft tissue infections (cSSTIs) pending Good Clinical Practice (GCP) inspections. ...