Physician Payment Sunshine: Survey Offers Insight Into Companies’ Phase One…
There was a recent survey of 32 compliance and regulatory officers and legal counsel from life science companies about…
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Yearly Archives
2014
FDA Final Rule: Postmarketing Safety Reports for Human Drug and Biological…
FDA released a final rule amending postmarketing safety reporting regulations for drugs and biologics so those subject to…
FDA Draft Guidance: Providing Submissions in Electronic…
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled…
Physician Payments Sunshine Act: With Just One Week Left for Data…
The Centers for Medicare and Medicaid Services (CMS) just released a reminder for manufacturers to complete 2013 data…
FDA: House Republicans Question Generic Drug Rulemaking Process
A large group of House Republicans is once against raising questions about the U.S. Food and Drug Administration's (FDA)…
Physician Payments Sunshine Act: PhRMA Urges CMS To Push Back June 30…
Last week, the Pharmaceutical Research and Manufacturers of America (PhRMA) wrote a letter to the Centers for Medicare…
Physician Payments Sunshine Act: Understand Physician Expectations and…
The 5th Aggregate Spend and Sunshine Conference, hosted by ExL Pharma, provided comprehensive insight into "lessons…
Accountable Care Update: Top ACO Providers
Accountable Care Organizations (ACOs) have proliferated throughout the United States in the past few years, but they are…
Accountable Care Organizations: Patients Look Elsewhere for Specialty Care
A study recently published in JAMA Internal Medicine found the majority of beneficiaries assigned to an accountable care…
FDA Social Media Guidance: Correcting Independent Third-Party…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…