Navigation Links
SNM applauds FDA's issuing of new drug manufacturing requirements
Date:12/14/2009

Reston, Va.The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

"We are pleased that FDA has issued cGMPs for PET drugs, which are so important to the diagnosis and treatment of patients with heart disease, cancer and other life-threatening illnesses," said Michael M. Graham, PhD, MD, president of SNM and director of nuclear medicine at the University of Iowa Carver College of Medicine.

The new FDA guidelines, which will take effect December 11, 2011, are aimed at ensuring that PET drugs meet all requirements of safety, identity, strength, quality and purity. The cGMP guidance document describes acceptable approaches that would enable PET drug producers to meet regulatory requirements. All PET drug manufacturers will be required to submit a new drug application (NDA) or abbreviated new drug application (aNDA) for all PET drug products in routine clinical use by the date of implementation. In the interim, U.S. facilities must continue to comply with U.S. Phamacopeia <823>, which sets standards for the production of PET drugs.

SNM worked in concert with other medical organizations to provide FDA input and review on the cGMP guidelines. "This is a major step forward," said Graham. "Having a well-defined structure in place benefits manufacturers, physicians and patients by ensuring the highest quality drugs possible."

Through its Clinical Trials Network, SNM will offer educational programs on the new regulation. Representatives from FDA will discuss the new guidelines with the molecular imaging and manufacturing community at two upcoming events. FDA representatives will present a special session during the Clinical Trials Network Workshop, which will be held Feb. 1𔃀, 2010, at SNM's Conjoint Mid-Winter Meetings in Albuquerque, N.M. In addition, FDA representatives will present a half-day workshop at SNM's Annual Meeting, June 5𔃇, 2010, in Salt Lake City, Utah. To date, more than 130 manufacturing sites have registered with the Clinical Trials Network.


'/>"/>

Contact: Amy Shaw
ashaw@snm.org
703-652-6773
Society of Nuclear Medicine
Source:Eurekalert

Related medicine news :

1. AIDS Healthcare Foundation Applauds City Commissioners Support of Diversity, Urges Call for Mayors Resignation
2. Fairness Coalition Applauds Senate Passage of Mental Health Parity Bill
3. SNM applauds NAS study showing need to restore federal nuclear medicine research funding
4. Cardiac Science Applauds Mass AED Training of Pittsburgh Educators
5. Coalition to Protect Floridas Drivers Applauds Governor Crist for Adding PIP to Special Session
6. AGD Applauds Congressional Support of SCHIP Reauthorization
7. Tobacco-Free Kids Applauds Tyra Banks for Exposing the Ugly Truth About Smoking
8. Health IT Now! Coalition Applauds Representatives Eshoo and Rogers for Introducing Health IT Legislation
9. Autism Speaks Applauds Supreme Court Decision Upholding Families Right to Challenge IEPs Without First Trying Out School District Proposed Placement
10. California Alliance Applauds Governors Support of Group Home Reform for Foster Youth
11. ASGE Applauds News of Drop in Colorectal Cancer Deaths
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2016)... ... 28, 2016 , ... May 26, 2016- In search of the K. Warriors, ... event of “K Warriors” on June 4, 2016 at Ashbury Hotel and Suites 600 ... sponsored and hosted by Shaolin Institute and sanctioned by KSF (Kungfu Sanda Federation), This ...
(Date:5/28/2016)... , ... May 28, 2016 , ... In a part of the city where’s it’s ... new farm-to-table Kelowna restaurants is hoping to attract diners with a taste for ... Suites officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on ...
(Date:5/27/2016)... ... May 27, 2016 , ... Southland Log Homes , designer ... timber frame barn kits, which can be found on its website at SouthlandLogHomes.com. , ... barn plans, and they highlight the craftsmanship of timber post and beam construction. ...
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. ... today that it has been recognized as one of the best small businesses for ... named as one of nine small businesses providing progressive benefits to new parents on ...
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent ... the demand for a sustainable product to aid in the rehabilitation process has steadily ... the recovery of individuals with hemiplegia due to stroke. , Ekso Bionics has now ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... SPRINGS, Florida , May 25, 2016 ... Business Conference & Expo earlier this month, the numbers ... As revenues continue to climb into the billions, more ... the newly released 4th Edition State of Legal Marijuana ... Frontier, a cannabis-focused data-analysis firm, much of the increase ...
(Date:5/25/2016)... , May 25, 2016 Digital Health ... to it by the US Patent and Trademark ... technology includes proprietary processes for electronic opt-­in and ... and wellness programs, HIPAA compliance and otherwise. ... "Our technology allows for ...
(Date:5/25/2016)... , May 25, 2016 ... the precision of circulating tumour DNA (ctDNA) analysis ... the appointment of Professor Clive Morris ... leadership across the clinical development programme, scientific collaborations, ... help deliver significant improvements in clinical outcomes for ...
Breaking Medicine Technology: