San Jose Facility Now Registered as Medical Device Establishment

submitted by: Chrom Solutions

Thermo Fisher Scientific's San Jose, California facility registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment. The site has established a quality system in accordance with the FDA Quality System Regulations to design and manufacture devices for analyzing samples from patients for in vitro diagnostic use.

Melanoma Brain Metastases and Vemurafenib: Need for Further Investigation

submitted by: WentzMR
Dr. Roxana Dronca, a Medical Oncologist, Senior Associate Consultant, and Assistant Professor of Oncology at Mayo Clinic in Rochester, MN, discusses her article appearing in the October 2012 issue of Mayo Clinic Proceedings where she confirms the need for continued vigilance for brain metastases in patients with BRAF mutated metastatic melanoma, despite simultaneous successful response of extracranial metastases to BRAF-targeted therapy with vemurafenib. Available at:...

Ten Common Questions (and Their Answers) About Off-Label Drug Use.

submitted by: WentzMR
Dr. Christopher Wittich, a General Internist at Mayo Clinic in Rochester, MN, discusses his article appearing as an Online First publication and in the October 2012 print issue of Mayo Clinic Proceedings, where he describes 10 common questions regarding off-label drug use and gives practical guidelines and clinical scenarios for where and when this routine practice is acceptable. Available at: http://www.mayoclinicproceedings.org/article/S0025-6196(12)00683-0/fulltext Visit the Mayo Clinic...

The High Cost of Cancer Drugs and What We Can do About it.

submitted by: WentzMR
Dr. S. Vincent Rajkumar, a Hematologist from Mayo Clinic in Rochester, MN, discusses his article appearing in the October 2012 issue of Mayo Clinic Proceedings, where he explains the reasons behind the high cost of cancer treatments in the US and provides several considerations for reducing these expenses. Available at: http://www.mayoclinicproceedings.org/article/S0025-6196(12)00738-0/fulltext Visit the Mayo Clinic Proceedings website: www.MayoClinicProceedings.org Find more videos:...

The High Cost of Cancer Drugs and What We Can do About it.

submitted by: WentzMR
Dr. Mustaqeem Siddiqui, a Hospitalist in Hematology and Oncology at Mayo Clinic in Rochester, MN, introduces his article appearing in the October 2012 issue of Mayo Clinic Proceedings on the high cost of cancer treatments. Available at: http://www.mayoclinicproceedings.org/article/ S0025-6196(12)00738-0/fulltext Visit the Mayo Clinic Proceedings website: www.MayoClinicProceedings.org Find more videos: www.YouTube.com/MayoProceedings Follow us on Twitter:...

Antiepileptic Drugs 2012: Recent Advances and Trends.

submitted by: WentzMR

Dr. Joseph Sirven, Professor of Neurology from Mayo Clinic in Phoenix, AZ, reviews his article appearing in the September 2012 issue of Mayo Clinic Proceedings, where he discusses 25 newly approved medications and 3 trends to aid in making the best clinical decisions for patients with epilepsy.
Available at: http://www.mayoclinicproceedings.org/article/S0025-6196(12)00678-7/fulltext

The Toxic Effects of Cigarette Additives. Philip Morris' Project Mix Reconsidered: An Analysis of Documents Released through Lit

submitted by: glantz
This video describes the peer reviewed paper, Wertz MS, Kyriss T, Paranjape S, Glantz SA (2011) The Toxic Effects of Cigarette Additives. Philip Morris' Project Mix Reconsidered: An Analysis of Documents Released through Litigation. PLoS Med 8(12): e1001145. doi:10.1371/journal.pmed.1001145 Background In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention on cigarette flavor additives. The tobacco industry had prepared for this...

Targeted Lymphoma Drug Works After Others Fail

submitted by: mdanderson

MD Anderson's Dr. Michelle Fanale, Hodgkin lymphoma survivor Alexandra Medina and research nurse Rinata Simien talk about newly approved drug brentuximab vedotin.

Family Smoking Prevention and Tobacco Control Act: Banning Outdoor Tobacco Advertising Near Schools and Playgrounds

submitted by: asorg
Background: The tobacco industry has challenged new FDA rules restricting outdoor tobacco advertising near schools and playgrounds on First Amendment grounds, arguing that they would lead to a near complete ban on tobacco advertising in dense urban areas. Purpose: To examine how the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA) rules banning outdoor tobacco advertising near schools and playgrounds would affect tobacco retailers. Methods: GIS spatial analyses of two...
Authors: Kurt m. Ribisl, Douglas a. Luke

FDA’s Moore on Where QbD’s Been, and Where It’s Going

submitted by: PharmaMfg

FDA CDER’s Christine Moore, PhD, acting deputy director of the Office of New Drug Quality Assessment, explains how her office is leading the Agency in moving from conceptual QbD to actual implementation. Gary Ritchie interviews (with a cameo from Emil Ciurcak).