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Pharmaceutical and Device
Chicago Releases Draft Rules on Industry Representative Licensure
In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of…
Citizens Petition Challenges FDA’s Off-Label Rule
On February 8, 2017, three organizations called on the United States Food and Drug Administration (FDA) to overhaul a newly…
FDA Announces Safety Labeling Changes Program
As reported by Regulatory Focus, the FDA announced the “safety labeling changes” (SLC) program. It will be reportedly…
Advanced BioHealing (Shire) Settlement Largest in Medical Device History
Earlier this month, the Department of Justice (DOJ) announced that Shire Pharmaceuticals LLC and other subsidiaries of Shire plc…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
President-Elect Donald Trump on the Pharmaceutical Industry
On Wednesday, January 11, 2017, President-Elect Donald Trump held a news conference in New York; a conference that was held out…
Why Do People Believe Drugs Are Too Expensive?
We have long heard from the media that the pharmaceutical industry “over charges” for prescription drugs and “makes money at the…
AHR Holds Congressional Briefing Focused on Cost Growth
The Alliance for Health Reform recently held a Congressional briefing about cost growth of pharmaceuticals in the Medicare program…
Tandem Price Increases: Legal or Price Fixing?
An article by reporters at Bloomberg recently highlighted the way United States prosecutors are beginning to crack down on generic…
A Win for Patients: Prop 61 in California Rejected
We recently wrote about Proposition 61 in California – a measure that would have required drug makers to provide large discounts…