Important Reminder of New PET (Positron Emitting Tomography) FDA Regulations

Going into Effect December 12, 2011

for

• Manufacturers of PET Imaging Agents
• Imaging Providers / M.D.s, Clinicians
• GxP Compliance Officers responsible for PET Imaging reagent compliance
• Management of Academic Research & Medical Centers / Hospitals / Imaging Facilities

The 21 CFR part 212 regulation is effective as of December 12, 2011.

• The regulation will become mandatory for PET drug production on this day.
• After this date a sponsor must have submitted a new drug application (NDA) or abbreviated new drug application (ANDA) for any PET drug product provided and/or marketed for clinical use in the United States.
• All PET drugs marketed under an NDA or ANDA must be produced in accordance with the requirements in 21 CFR 212.
• Producers of investigational PET drugs and research PET drugs, will have option to follow the requirements in 212 or to produce PET drugs or in accordance with USP USP 32/NF 27 (2009).

These PET imaging agents are currently used in patients participating in investigational clinical trials and in patient case management. This regulation enables the production and marketing of PET imaging agents as approved imaging agents in the diagnosis of disease state as well as in the patient case management decisions in conjunction with approved or investigational therapeutic agents used to treat them. Thus, adherence to the above regulations assures no PET imaging agent is used in diagnosis and patient management decisions that has been produced non-compliantly and this assures patient safety.

PAREXEL Consulting offers a unique, turn-key solution to help responsible parties meet the December 2011 requirements and prevent shut-down of operations. We can also help parties conduct proactive GLP, GCP and GMP assessments to prevent shut-down or other actions due to quality issues / non-compliance.

We offer:

• A dedicated project team to help facilitate electronic submission of the required NDAs or ANDAs. Our key experts include:
• Formerly Division Director of Medical Imaging and Hematology Products in the Office of Oncology Drug Products at FDA’s CDER
• Branch Chief in the Office of New Drug Quality Assessment, FDA, and CMC Radiopharmaceuticals Expert
• Former FDA Project Managers
• Former FDA GxP (GLP, GCP, GMP) compliance officers with average 25 years experience with FDA
• Our consistent approach of these electronic submissions will help facilitate more timely review by FDA

Let us assist you in meeting these requirements in a timely, efficient manner. Call Neil Butera today at + 1 585 723 1211 or e-mail him at Neil.Butera@PAREXEL.com.

Please see our recent article on this topic:

Food and Drug Administration Requirements for Testing and Approval of New Radiopharmaceuticals Seminars in Nuclear Medicine, Volume 40, Issue 5, September 2010, Pages 364-384
By Ravi Harapanhalli, Principal Consultant, PAREXEL Consulting