FDA Guidance: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

FDA issued the following guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions."  The guidance is intended to clarify the requirements if 21 CFR 312.120 and it also provides recommendations for IND's or MAA"s on how to provide evidence of GCP compliance of a non-IND foreign clinical study. 

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

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FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to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)