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The House appropriations subcommittee that oversees FDA funding recommends a fiscal 2013 budget that would slightly reduce agency spending.
Pharma companies seeking approval for drugs along with companion diagnostics could see more streamlined FDA decisions as the agency moves toward a stricter preapproval path for the diagnostic portion of companion products.
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.
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