The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.”
Home » Events » Understanding the U.S. Biosimilar Pathway in 2012 An In-Depth Look at the Debate and Its Implications
FDAnews has called on two experts in regulatory law, Covington & Burling’s Erika Lietzen and Laura Sim, to explain what the FDA is trying to do, how the public comments might change the landscape and what you need to know NOW in order to stay out in front.
Audio CD/Transcript - June 28, 2012
The Audio CD/Transcript will be shipped the week of July 23, 2012.