FDA: The Differences with Pharmaceutical and Device Promotion Standards
Over the years we have noted in our coverage of FDLI's Enforcement and Litigation Conference that DOJ and other officials…
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PhRMA and Local Pharmacists Litigate to Stop Maine Pharmaceutical…
As reported in the Wall Street Journal and Smart Brief: "Businesses are confused as to whether to act now or wait for the U.S.…
Physician Payment Sunshine Act: CMS To Host Call on NPPES and PECOS…
With the Physician Payment Sunshine Act period of reporting for 2013 drawing to a close end, it will be critical for all…
Physician Payment Sunshine Act: Congressman Calls for Meals Exemption for…
The Physician Payment Sunshine Act (Open Payments) Final Rule has not clarified all of the expectations under the law. The…
FDA OPDP: Announces Accredited CME Course for Bad Ad Program
In May 2010, the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) launched the Bad Ad program.…
Johnson and Johnson Corporate Integrity Agreement: The Progression of Life…
Compliance managers at pharmaceutical companies and medical device manufacturers can stay ahead of enforcement trends by…
Physician Payment Sunshine Act: CMS to Host Education for Company…
According to a release from the Centers for Medicare & Medicaid Services (CMS), in response to stakeholder requests, on…
FDA Draft National Adverse Event Plan
Adverse drug events (ADEs) have been defined as an injury resulting from medical intervention related to a drug. ADEs can occur in…
Health Leaders Call for Reformation of the Physician Certification Process
A recent post at Health Affairs blog calls for reforming the physician certification process. It is authored by Dr. Alan Muney,…
FDA: A Parents’ Guide to Kids’ Vaccines
The FDA has unveiled a "A Parents' Guide to Kids' Vaccines" on its website. The website outlines several key areas:…