Tag Archives: Implementation

FCA Releases Near Final Rules on SMCR Extension to the rest of the FS Industry and confirms implementation date

Today, the FCA published the long-awaited near final rules on the extension of the SMCR to those firms regulated by the FCA only: PS18/14 – Extending the Senior Managers and Certification Regime to FCA firms The Senior Managers and Certification … Continue reading

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What is the position of the UK in the ESAs during the implementation period?

On 13 June 2018, HM Treasury published a letter that it had sent to the chair of the House of Commons’ European Scrutiny Committee, Sir William Cash MP. In the letter HM Treasury discusses the position as regards UK representation … Continue reading

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Burden of “Right to Try” Implementation on Sponsors (for Now); Risk of Unexpected SAEs Negatively Impacting Development and Approval Still Remains

By James E. Valentine & David B. Clissold — On May 30, 2018, the federal “Right to Try” law was enacted, creating a new legal framework for access to investigational drugs in limited situations outside of a clinical trial. See … Continue reading

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Fifth Delay for 340B Final Rule Implementation

By David C. Gibbons & Alan M. Kirschenbaum — On June 1, 2018, the Health Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the … Continue reading

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HHS Weighing Additional 1-Year Delay in 340B Ceiling Price/CMP Rule Implementation

The Department of Health and Human Services (HHS) is seeking comments on an additional delay in the effective date of the January 5, 2017 Health Resources and Services Administration (HRSA) final rule addressing calculation of the ceiling price and application … Continue reading

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