Navigation Links
FDA, SNM and RSNA host April 13-14 two-topic imaging workshop

Reston, Va.The U.S. Food and Drug Administration (FDA), SNM and the Radiological Society of North America (RSNA) are hosting a joint twotopic workshop, April 13-14, 2010 at the Natcher Conference Center of the National Institutes of Health, Bethesda, Md. The first day of the workshop will focus on general issues of standardization to control variability and inconsistency in methods of acquisition, interpretation and analysis of images in clinical trials. The second day of the workshop consists of an interactive tutorial on ways to address the FDA regulatory expectations for positron emission tomography (PET) drugs, particularly with respect to the recently issued regulations establishing the Current Good Manufacturing Practice (cGMP).

"This workshop offers a unique opportunity to work with the imaging community to help optimize the role of imaging in public health," said Dwaine Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research. "This is an example of the FDA's focus on transparency and its collaboration with stakeholders to ensure that regulated products are both safe and effective."

"We are delighted to be partnering with the FDA and RSNA to bring the molecular imaging community together on the important transition to the new regulations," said Michael M. Graham, Ph.D., M.D., president of SNM. "The PET community remains very focused on preparing to comply with these regulations and is committed to working together to ensure a smooth transition."

"We are very pleased to be working with the FDA and SNMand the wider communityto discuss critical issues central to the use of imaging as an endpoint in clinical trials," said Daniel Sullivan, M.D., RSNA Science Advisor. "Standardization is essential to improving the value and practicality of imaging biomarkers."

The FDA published a final regulation on current good manufacturing practice (CGMP) for the production of PET drugs in December 2009. The new regulations, known as 21 CFR Part 212, take effect on Dec. 12, 2011. All PET drug manufacturers will be required to submit a new or abbreviated drug application for PET drugs in commercial/clinical use by that date. In the interim, U.S. facilities must continue to comply with USP General Chapter <823>, which sets standards for the production of PET drugs.

The workshop is free and open to the public. However, early registration is encouraged as space is limited. To register, please visit


Contact: Amy Shaw
Society of Nuclear Medicine

Related medicine news :

1. First Ever Virtual Autism Conference Featuring Temple Grandin and 16 speakers to discuss: &#8220;Things To Know About Autism&#8221; April 10th-11th.
2. Off the Beaten Path, LLC - Savings On 2010 Loire Valley Tours: Save $350 Per Person When Reserving by April 15
3. Childrens Mental Health Conference Brings Together Top Research, Professionals, Parents and Community Agencies, April 8-9 in Miami
4. Central Illinois Electronic Health Records Summit Coming in April; Medical Conference Offered In Three Central Illinois Locations
5. Alert: Bloomberg to Gather Healthcare Experts in Chicago, April 27th
6. Nine Healthcare Companies Named Finalists for Innovations in HealthcareSM ABBY Awards, to be Presented April 28th
7. March/April 2010 Annals of Family Medicine tip sheet
8. Blue Cross and Blue Shield Companies To Host Fourth Annual National Walk@Lunch Day(R) on April 28, 2010
9. Register Online for this Year's Horst Senior Living Conference on April 8 Featuring Keynote Speaker and Senior Housing Expert Jim Moore
10. HITSP Contract With U.S. HHS Extended Through April 2010
11. Global Healthcare & Medical Tourism Conference Korea Announced for April 13-16th, 2010
Post Your Comments:
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and Grand ... Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will be ... Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph Collection ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/5/2017)... 5, 2017  In response to the nationwide ... Maxillofacial Surgeons (AAOMS) released prescribing recommendations that urge ... used as a first-line therapy to manage a ... Recognizing the value and importance ... "Opioid Prescribing: Acute and Postoperative Pain Management" stresses ...
(Date:10/4/2017)... Mass. , Oct. 4, 2017 ... of single-use, self-contained, illuminating medical devices, today announced ... National Health Surveillance Agency (or Agência Nacional de ... The first single-use, cordless surgical retractor with integrated ... provides optimal access, illumination and exposure of a ...
Breaking Medicine Technology: