Navigation Links
SNM applauds FDA's issuing of new drug manufacturing requirements

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
Society of Nuclear Medicine

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:
(Date:11/27/2015)... Rosa, CA (PRWEB) , ... November 27, 2015 , ... ... Northern California Medical Associates, Inc. and Dr. Tucker Bierbaum with Emergency Medicine at ... meeting. They observed that both STEMI and Sepsis conditions present in similar ways and ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... Inevitably when ... Many customers choose to buy during the Black Friday and Cyber Monday ... don’t need to search the Internet high and low to find the best massage ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical laboratories ... and offered by healthcare staffing agency Aureus Medical Group . These ... October 2015 among those searching for healthcare jobs through the company’s website, ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... consultation, has collaborated with Women’s Web – an online resource for Indian ... on mental and emotional well-being relationship, life balance, stress, professional development, and ...
(Date:11/25/2015)... ... 25, 2015 , ... The holiday season is jam-packed with ... palates of attendees is of the utmost importance. Whether you are cooking at ... these recipes a try this holiday season. , Turkey Croquettes , ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015  Amgen (NASDAQ: AMGN ) today announced ... the United States (U.S.) Food ... candidate to Humira ® (adalimumab). Amgen believes this ... the FDA and represents Amgen,s first BLA submission using ... , M.D., executive vice president of Research and Development ...
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, a ... treatment outcomes for patients suffering from chronic pain, said ... a Temporary Restraining Order (TRO) enjoining Express Scripts from ... companies. --> --> ... of its legal options. --> ...
(Date:11/25/2015)... ATLANTA , Nov. 25, 2015 ... the first federal bellwether trial against Wright Medical ... relating to their Conserve metal-on-metal hip implant device, ... Christiansen.  Following a two week trial and three ... Conserve metal-on-metal hip device was defectively designed and ...
Breaking Medicine Technology: