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January 15, 2010 (Vol. 30, No. 2)

Expanded Access to Investigational Drugs

New FDA Regulations Provide Effective Framework, but Questions Remain

  • You’ve got a drug in the pipeline that’s showing great promise. Results from your clinical trials are making news. What happens when you start getting calls from physicians and desperately ill patients requesting access to the drug prior to final approval? Who takes the call? What is your response?  ...

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