Category Archives: Manufacturing

Pharma 2012 Layoffs

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?

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 compliance, FDA, Regulatory | 1 Comment

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

Also posted in compliance, Corporate Responsibility, FDA, News, Strategy | 1 Comment

SciClone Pharmaceuticals: Selling Specialty Drugs in China

US-based SciClone Pharmaceuticals has built its business around selling specialty drugs in China. Companies like Sanofi and Pfizer, despite their own in-country resources, have partnered with SciClone and are achieving better returns, according to SciClone CEO Friedhelm Blobel.
Also posted in Biotech, compliance, Emerging Markets, Global, healthcare, IP, Legal, People, pricing, Regulatory, Sales, Strategy | Tagged , , | 1 Comment

FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to […]
Also posted in FDA, Guest Blog, IP, Legal, Market Access, Meetings, Regulatory, Safety, Strategy, Technology | Tagged , | 1 Comment
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