October 2014
- Guidance for Industry and Staff: Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests
Tuesday, September 30, 2014
Reminder FDA Guidance Regarding Laboratory Developed Tests
FDA CDER System of Records including those for compounded and unapproved drugs
F]CDER System of Record (PDF - 103KB) 
www.fda.gov/.../UCM416566.pdf
Food and Drug Administration
BREAKING: Open Payments website launches By Jaimy Lee Posted: September 30, 2014 - 1:45 pm ET
The federal government today launched a highly anticipated website detailing at least $3.5 billion in financial ties in a five-month period between medical device and drug companies and physicians and teaching hospitals.
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
continue to read here
Morning Break: Pharma $$ to Docs Database Opens Published: Sep 30, 2014 By MedPage Today Staff
http://www.medpagetoday.com/PublicHealthPolicy/GeneralProfessionalIssues/47877?isalert=1&uun=g649657d2242R5784224u&utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news&xid=NL_breakingnews_2014-09-30
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