Drug/Device and Device/Drug Combinations in the EU and USA

Apr 20th, 2015Apr 21st, 2015
London, H9
GB
http://www.management-forum.co.uk/pharmaceutical/events/drugdevice-devicedrug-combinations-eu-usa/
Phone:+44 (0) 1473 730071
Practical guidance on borderline issues and combination products.
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F-18 fluciclovine PET/CT images in a 59-year-old man with biochemical recurrence after prostatectomy (prostate-specific antigen level, 0.42 ng/mL; Gleason score, 5 + 4 = 9; T3BN1M0). (A) Coronal PET and (B) maximum intensity projection images show multiple retroperitoneal lymph nodes with abnormal radiotracer uptake (arrows). (C) Axial PET and (D) axial fused PET/CT images show the index lesion (arrow), measuring 13 × 10 mm, on the right precaval lymph node. The initial decision to offer radiation therapy to the prostate bed and pelvis was changed to a decision not to offer radiation therapy.
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