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:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... ... is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is ...
(Date:6/24/2016)... TX (PRWEB) , ... June 24, 2016 , ... People ... part in Genome magazine’s Code Talker Award, an essay contest in which patients and ... an award to be presented at the 2016 National Society of Genetic Counselors (NSGC) ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
Breaking Medicine Technology: