FDA National Direct to Consumer Advertising Survey – Again
If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug…
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PDFUA-MDUFA Update March 2016
Last year, the U.S. Food and Drug administration kicked off the reauthorization process for MDUFA, or the Medical Device…
CMS Opens Physician and Teaching Hospital Registration for Open Payments…
CMS has announced that the Open Payments system is now open for physician and teaching hospital registration. While…
Biogen Joins the Center for Therapeutic Target Validation
The Center for Therapeutic Target Validation (CTTV) has a new member to boast about, helping them improve the success…
CMS Proposed Rule Drastically Changes the Way Medicare Pays for Part B…
The Centers for Medicare and Medicaid Services announced their proposal to test new Medicare Part B prescription drug…
Amarin and FDA Off Label Free Speech Settlement
The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement…
Endo New York Settlement Announcement
New York Attorney General Eric T. Schneiderman announced an agreement with Endo Health Solutions, Inc. and Endo…
Tenet Healthcare Settlement Offer
Tenet has been locked in a legal battle against allegations that four of its hospitals violated the Anti-Kickback Statute and the…
FDA Draft Guidance: Best Practices for Communication Between IND Sponsors…
To guide investigational new drug application (IND) sponsors' communication with the FDA during development phases, a…
New Indicators Show Prescription Drug Spending Increased Slower than…
We have been hearing for years now that the pharmaceutical industry is the reason for the spike in healthcare costs,…