ComplianceOnline articles

Abstract:

There`s a lot of buzz around HCCs in the healthcare. But not everyone understands why and how to use them. Coding and auditing errors can have a negative impact on the organization’s revenue cycle. Hospital and clinical staff, including Directors, Auditors, CDI staff, Managers, CDI Clinicians and coding compliance and privacy staff should understand the key components of the HCC coding and auditing.

Abstract:

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. Th

Abstract:

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warnin

Abstract:

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.

Abstract:

Credit risk, market risk, operational risk, counterparty credit risk, interest rate risk, and capital floors – a list of things on the itinerary for Basel IV. While yet adjusting to the requirements of Basel III, the newer legislation will hit the financial market soon enough, bringing with it a flurry of rules to mitigate any signs of a financial crisis akin to the 2007-2009 collapse.

Basel IV reaches up and sets the bar higher for capital ade