positron emission tomography

• Positron emission tomography

• Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' This guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.

• Federal Register Nbr. 77 FR 21783, April 11, 2012
• Notices
• Health and Human Services Department

• Positron Emission Tomography As a Tool for Studying Alcohol Abuse

PET analyses using FDG to measure brain glucose metabolism and radiolabeled water to measure cerebral blood flow have been used to study the acute and chronic effects of alcohol in nonalcoholic control subjects, alcoholics, and people at risk of alcoholism (e.g., children of alcoholics).

• Alcohol Research and Health
• Vol. 31 Nbr. 3, July 2008

• Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The draft guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs).

• Federal Register Nbr. 77 FR 8262, February 14, 2012
• Notices
• Health and Human Services Department

• Neuroscience-Based Lie Detection: The Urgent Need for Regulation

While the earliest reliable noninvasive method, electroencephalography (EEG), used electrical signals to localize and quantify brain activity, measures of metabolic activity using positron emission tomography (PET) and single photon emission computed tomography (SPECT) followed a few decades later in the 1960s.7 EEG studies had exceptional benefits for revealing cognitive processing on the subsecond level, localizing epileptogenic foci, and monitoring patients with epilepsy. Penfield's corticography work enabled even more accurate measurements from recordings made directly from the cortex during neurosurgery.8 PET and SPECT have been used widely in basic research studies of neurotransmission and protein synthesis, further advancing our knowledge of neurodegenerative disorders, affectiv...

• American Journal of Law and Medicine
• Vol. 33 Nbr. 2/3, April 2007

• Guidance on Positron Emission Tomography Drug Applications; Availability:

• FR, September 01, 2011
• Notices
• Food and Drug Administration

• Current Good Manufacturing Practice for Positron Emission Tomography Drugs

• FR, December 10, 2009
• Rules
• Food and Drug Administration

• Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.

• Federal Register Nbr. 77 FR 11553, February 27, 2012
• Notices
• Health and Human Services Department

• Human drugs: Positron emission tomography drug products; current good manufacturing practice,

• FR, September 20, 2005
• Proposed rules
• Food and Drug Administration

• 'I'm Cancer Free'

CHESAPEAKE The chemotherapy is over for Libby Ryder, and so is the waiting, the wondering, the "what if?" // The Positron Emission Tomography scan came back clean. That allows Libby, whose "don't waste your cancer" blog is approaching 280,000 hits, to tell her husband and the world : "I 'm cancer free.

• The Virginian-Pilot and The Ledger-Star, Norfolk, VA
• February 28, 2011

• Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability

• FR, December 10, 2009
• Notices
• Food and Drug Administration