9 Articles found
ComplianceOnline Articles
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Understanding compliant HCC coding and auditing
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, ...
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Receipt and storage of cGMP controlled raw materials regulations and best practices
Abstract: Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, ...
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FDA revises cGMP and labeling regulations of medical gases
Abstract: The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were ...
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Beyond Basel iii: What does Basel IV promise?
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 ...
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Embracing Q3D: FDA`s new elemental impurities guidance
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 ...
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DHS issues guidance on HIPAA and cloud computing
Abstract: DHS Issues Guidance on HIPAA and Cloud Computing Cloud computing, an indelible part of healthcare systems and networks today, will now be regulated and brought under the HIPAA fold. DHS released the guidance that details the requirements ...
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What’s Safe in Your Medicine Cabinet: Dietary Supplements in the U.S.
Abstract: What`s Safe in Your Medicine Cabinet: Dietary Supplements in the U.S. From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin ...
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Lack of robust regulations for generic drugs warning labels leads to outcry
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 ...
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Risk information in prescription drug & medical device ads, promotional labeling – What the FDA expects
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 ...