Category Archives: Manufacturing

The Sunshine Act: Cloudier Still?

By Clark Herman | Published: February 7, 2013
With the recent release of the Patient Protection Sunshine Act (PPSA), the Center for Medicare and Medicaid Services (CMS) has established reporting requirements to ensure that drug manufacturers properly disclose payments to physicians in areas of research, continuing medical education, etc. However a key uncertainty is the issue of state pre-emption. While state and local [...]
Also posted in Legal, Medical Education, Meetings, Regulatory, compliance | Tagged , , | 1 Comment

Amid Flu Epidemic a Focus on Vaccine Innovation

By Reid Paul | Published: January 29, 2013
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Also posted in Biotech, Europe, FDA, R&D, Video | Leave a comment

Pharma 2012 Layoffs

By Reid Paul | Published: January 9, 2013
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Also posted in Emerging Markets, Europe, Global, Marketing, News, People, R&D, Sales, Strategy, Video | Leave a comment

Dissecting ACA's Section 6004: Tipping the Balance on Sampling Controls?

By Clark Herman | Published: November 14, 2012
With the Affordable Care Act [ACA] officially settling into the US’ political landscape, a pressing – but little noticed – issue is the provisions for increased compliance on industry promotion practices.  Of specific concern is Section 6004 of the ACA, which demands more rigorous reporting on the distribution of free samples to physicians from pharmaceutical [...]
Also posted in FDA, Regulatory, compliance | 1 Comment

Video: Should Pharmacies Be Held to the Same FDA Standards?

By Reid Paul | Published: October 10, 2012
Also posted in Corporate Responsibility, FDA, News, Strategy, compliance | 1 Comment