FDA Social Media Guidance: Presenting Risks and Benefits With Social…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…
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Yearly Archives
2014
Physician Payments Sunshine Act: Issues To Watch For As You Submit Phase 2…
Pharmaceutical and device manufacturers must submit detailed data on payments to physicians and teaching hospitals to comply with…
New Enforcement Frontier? Medtronic Settles Medical Device Kickback Case…
A number of government attorneys have spoken at compliance conferences over the last year and noted that the days of…
GSK Settles for $105 Million Under State Consumer Protection Laws; Agrees…
GlaxoSmithKline reached a $105 million settlement with 44 states and D.C. to resolve allegations that the company unlawfully…
Physician Payments Sunshine Act: CMS Pushes Dispute Resolution to…
The Centers for Medicare and Medicaid Services (CMS) held a webinar yesterday aimed at physicians and teaching…
Physician Payment Sunshine: Minnesota Expands Reporting “Practitioner”…
Despite opposition by the Minnesota Board of Pharmacy, the Minnesota legislature passed HF 2402, which one section requires…
CME Coalition Model Privacy Policy for All CME Providers
Continuing medical education (CME) providers must be cognizant of privacy issues regarding their physician clients. The…
Physician Payments Sunshine Act: AMA House of Delegates Passes Resolution…
Meeting this week in Chicago, the American Medical Association (AMA) House of Delegates overwhelmingly passed two…
Stakeholders Argue FDA’s New Reprint Guidance Is Unworkable and “Omits Any…
In March, we covered FDA's revised guidance for manufacturers seeking to distribute scientific journal articles that…
FDA Launches – Open FDA
In early June, the U.S. Food and Drug Administration (FDA) launched openFDA, a new initiative designed to make it easier…