UK’s Version of EFPIA Disclosure: Bred with the Sunshine Act in Mind
Recently, we wrote about the transparency and disclosure changes coming to Europe, and promised a more in-depth view of…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
EFPIA Disclosure “Sunshine Act – Lite”
For the first time, on June 30, 2016, pharmaceutical companies will be forced to disclose full data on payments made to…
Physician Payment Sunshine: Canadian Style
According to a report, 10 Canadian-based firms have agreed to divulge the amount of money they give to physicians and…
JAMA: Research Parasites Wanted
As reported, earlier this year, a top medical journal ignited a backlash by referring to "research parasites", also…
MedPAC Votes for Sweeping Revisions to Medicare Part D
The Medicare Payment Advisory Commission (MedPAC) an important advisory panel to congress, voted to back a package of…
Update on Patient Participation in Medical Products Discussions
When President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, it…
FDA to Conduct Studies in Pharmaceutical Manufacturing
According to a recent report, the FDA is looking for companies to participate in a program that will review the latest…
FDA: Biosimilars Labeling Guidance
After several delays the FDA has finally released its draft guidance that says a biosimilar's label does not have to be…
Update on Biosimilars US Regulation 1st Quarter 2016
Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the…
MedPAC Meeting on Part B Drug Payment Policy
The Medicare Payment Advisory Commission held a meeting on Part B drug payment policy issues. The meeting focused on the…