industry news

Tuesday, June 8, 2010

Deadline Approaches - Submission of Massachusetts Disclosure Report

The pharmaceutical industry, in a number of states, is currently required to track and in some cases, report on promotional activities, such as gifts, meals, consulting fees, and grants provided to healthcare professionals. These disclosures consist of the value, nature and purpose of gifts, payments, or other economic benefits provided to healthcare professionals in the advancement of a drug product or service. It is vital that all companies understand and comply with current marketing and advertising disclosure laws. With the state’s first disclosure report due in less than one month, it is critical that companies understand the Massachusetts reporting requirements for physician payments.

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Wednesday, June 2, 2010

Vermont Passes Legislation

On May 27, 2010, Vermont Senate Bill 88 An act relating to health care financing and universal access to health care in Vermont (S.88) became law, without the Governor’s signature. Among other things, S.88 amends Vermont's Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General's Office all free samples of prescribed products provided to health care providers during the preceding calendar year. The bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information.

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Thursday, May 20, 2010

FDA Training Videos: Introduction to Device Software Regulation

The Food and Drug Administration (FDA) has posted its first CDRHLearn video presentation on software regulation. The presenter is one of FDA's Software Compliance Experts John Murray. This is the first of several software training modules.

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Tuesday, May 18, 2010

FDA To Audit Pharma's Electronic Recordkeeping

In a bid to evaluate the pharmaceutical industry's compliance with a regulation known as 21 CFR Part 11, which is all about the growing and vast use of electronic records, the FDA is about to begin a series of so-called inspectional findings at many drugmakers.

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Monday, May 17, 2010

QPharma's Spring 2010 Newsletter

Click here to download our Spring 2010 newsletter

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Thursday, April 22, 2010

WHO Invites Comments on Draft Guideline

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Wednesday, March 31, 2010

New ISPE GAMP^®Good Practice Guides now available

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Tuesday, March 23, 2010

H.R. 3590: Patient Protection and Affordable Care Act

President Barack Obama signed the health care reform bill (HR 3590 - Patient Protection and Affordable Care Act) into law at the White House on Tuesday, March 23, 2010

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