FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. Read the guidance at www.fda.gov: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 461KB)
Compliance News: A blog on regulatory compliance and quality assurance topics, including current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
14 February 2012
FDA Guidance: IND Applications for PET Drugs
FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. Read the guidance at www.fda.gov: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 461KB)
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