Compliance & Risk Archives | Report Store

FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

Democratic senators push data-challenged gene therapy Zolgensma into the center of the drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Did the FDA do the right thing by abandoning a proposed rule that, as they state, is not needed to protect research subjects or ensure integrity of clinical trial data?

August 2, 2019

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FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

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A new Technical Information Report from the Association for the Advancement of Medical Instrumentation aims to help befuddled US device makers that operate under the FDA’s QSR ensure they are compliant with standard from the ISO.

August 2, 2019

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ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

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The most recent version of International Standardization Organization’s ISO 13485 hasn’t even gone into effect yet and already the Technical Management Board is looking for a rewrite, calling for the standard to be rewritten in a “high-level” format. Find out more here.

November 2, 2018

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Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

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Medtech Insight’s Compliance Corner is back for the final installment of the three-part series on Investigator Horror Stories. Tap into the recollections of top industry insiders for a jaw-dropping look at some of the more outrageous tales from the world of compliance.

October 22, 2018

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Thinking about using CMMI? Here are tips from the experts

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Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.

June 25, 2018

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Sunshine rules in the EU: Implications of a piecemeal approach

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The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.

June 1, 2018

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Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 ‘In The Coming Years,’ Official Says

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Global regulators are looking to converge–or at least align–various requirements, and the US FDA is no exception. Officials have strongly suggested that the agency will replace its Quality System Regulation with ISO 13485. It won’t be simple. Discover the implications for device makers, and find out what’s involved in making this dramatic change.

May 4, 2018

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