Category Archives: Manufacturing
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 [...]
By Reid Paul | Published: October 10, 2012
By Ben Comer | Published: October 1, 2012
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.
By Guest Blogger | Published: September 5, 2012
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 [...]