The wait is over but now, what does it mean? Let’s look at the definition of the Sunshine Act, its focus and how it will impact organizations. First, according to the Federal Registry, the Sunshine Act also known as the Transparency Reporting of Physician Ownership of Investment Interests requires: “…applicable manufacturers of drugs, devices, biologicals, [...]
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The indications are clear: Recent Corporate Integrity Agreements (CIAs) have underscored the fact that there is “a new normal” for compliance programs. The new normal includes: In-depth Code of Conduct training requirements; Required dissemination of policies on topics such as interactions with Health Care Professionals (HCPs); Bans on gifts; A tough anti-bribery stance; Aggressively seeking [...]
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Have you ever wondered how some companies seem to have more than just good quality training? They seem to have an entire quality structure. They have the procedures, policies and activities in place that provide a structure that fosters quality. Learn the secrets of these companies in an exciting webinar to be held on May [...]
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According to a recent FDA presentation at an AdvaMed MTLI workshop, one of the most common observations from FDA BIMO sponsor-related investigations in 2012 was: “Failure to secure investigator compliance” We wanted to gain a deeper understanding of FDA’s expectations by reviewing a 2011 warning letter in which this observation [21 CFR 812.46(a)] was cited. [...]
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Are New Regulations on the Horizon for Compounding Pharmacists?
Posted on 16. Apr, 2013 by Karl Kapp.
An interesting article in The Washington Post titled, “Pharmacy Trade Group Shifts Position on Federal Oversight” talks about a shift in position by the International Academy of Compounding Pharmacists. The Academy is now taking the stand that it will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug [...]
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UL Quality, Compliance and Learning constantly works diligently with the FDA to ensure we have the latest information on upcoming and newly implemented mandates and policies. A great deal of this is due to our unique relationship with the FDA. See the post The FDA, a CRADA and You: What does it all mean? An [...]
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The Office of Inspector General (OIG) is tasked with protecting program integrity and the well-being of program beneficiaries by detecting and preventing fraud, waste and abuse, identifying opportunities to improve program economy, efficiency and effectiveness and holding accountable those who do not meet program requirements or who violate Federal laws. The current Inspector General is [...]
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Too often companies take a “shot gun” approach to compliance training. The company pumps out training with a “one topic fits all” approach that fails to target the knowledge gaps of employees and, just as important, fails to target the need for the company for a well trained workforce. Here are some guidelines for creating [...]
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Before a Generic Pharmaceutical Association’s meeting held February 2013 in Florida, Margaret Hamburg, the US Food and Drug Administration (FDA) Commissioner, stated that the FDA has “chosen to make quality one of our highest priorities this year and we’d like you to do the same.” She indicated that without product quality, none of us can [...]
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