Novartis Kickback Case Will Continue, Rules Federal Judge; What We Can…
Novartis must continue to litigate over its speaker programs, District Court Judge Paul G. Gardephe ruled earlier this…
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Physician Payments Sunshine Act: Medical Societies Express Strong Support…
Last month we wrote about a bipartisan effort in Congress to exempt medical textbooks and journals, as well as indirect…
FDA-CMS Parallel Review Process Brings Its First Device to Market
Getting a medical device to market is not easy. The Food and Drug Administration (FDA) approval process alone can take…
Don’t Delay: FDA Finalizes Guidance on “Circumstances that…
An FDA inspection consists of a “careful, critical, official examination of a facility to determine its compliance with…
FDA Responds to Zohydro Painkiller Criticism
Last year, the Food and Drug Administration (FDA) approved an opioid pain relief drug called Zohydro. Zohydro is an…
Drug Shortages Update
Thomas Sullivan
Over the years we have discussed the impact of drug shortages on healthcare in the United States. With…
Mining Social Media for Adverse Events
In February, the FDA released a Request for Proposal asking firms to help the agency monitor social media activity for…
ABA Health Law Event: FDA Medical Device Law Fundamentals
On November 20, 2014, hear an experienced panel discuss FDA Medical Device Law Fundamentals. Policy & Medicine readers will…
Physician Payments Sunshine: Germany Implements EFPIA Disclosure Code,…
In Germany, the association “Freiwillige Selbstkontrolle für die Arzneimittelindustrie” (FSA, “Voluntary Self-regulation…
“No Advertising Please”: Australia Campaign to Stop Pharma Rep…
Australia's industry body Medicines Australia recently got the ball rolling on their own physician payments disclosure…