Washington Drug Letter

The FDA has handed Merck a complete response letter on Taltorvic, a potential maintenance treatment for metastatic soft-tissue and bone sarcomas, calling for additional clinical trials to assess safety and efficacy.

The FDA has revised its guidance on testing a new drug’s genotoxicity to help drugmakers optimize the standard genetic toxicology battery and better predict potential human risks.

Pharma companies seeking approval for drugs along with companion diagnostics could see quicker FDA decisions as the agency moves toward a stricter preapproval path for the diagnostic portion of companion products.

BALTIMORE — Despite recurring pharma quality problems, drugmakers are still inclined to meet minimum manufacturing standards set by regulators, rather than make quality central to their business model.

The House appropriations subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending.

BALTIMORE — Proposed language redefining current good manufacturing practices (cGMP) included in both versions of omnibus FDA user fee legislation appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.