ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further […]

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Deadline Alarm Clock

21st Century Cures Act— 11 February 2017 = Deadline for Company Disclosure of Expanded Access Programs

The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition[2] must make available such company’s […]

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The Good, the Bad and the Unresolved: Proposed Changes to the UK Market Access for Medicines

In October 2016, the National institute for Health and Care Excellence (NICE) and National Health Service England (NHS England) launched a 12 week consultation on proposed changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s Technology Appraisal (TA) and Highly Specialised Technologies (HST) programmes. The consultation closed on […]

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Office of Inspector General, U.S. Department of Health and Human Services.  (PRNewsFoto/Office of Inspector General Department of Health and Human Services)

HHS OIG Publishes Final Rule on Anti-Kickback Statute: Safe Harbors And Monetary Penalties

On December 6, 2016 the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued two final rules relating to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP). These rules affect a wide variety of health care companies and also impact False Claims Act investigations and litigation. The first rule “amends […]

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HIPAA document with magnifying glass

First HIPAA Enforcement Action of 2017 – Failure to Provide Timely Notice of Breach to OCR

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) has announced its first Health Insurance Portability and Accountability Act (HIPAA) settlement of the year regarding the untimely reporting of a breach of unsecured protected health information (PHI). The OCR settlement is with Presence Health, an Illinois health care network with […]

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The word 'Brexit' from a newspaper headline, following the UK decision to leave the European Union, following a public referendum held on 23rd June 2016.

What Brexit Means for Health Products

Source: Robert Breedon, partner at Gowling WLG and Head of the Health and Care Sector While concern undoubtedly persists across the board about the potential business implications of Britain leaving the EU, it appears that US health product manufacturers and providers are broadly taking a more optimistic view. Indeed, nearly half of the health product […]

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Close up of personal information form with confidential stamp

Guidelines for De-Identification, Anonymization, and Pseudonymization

Source: Christopher M. Achatz, Associate, Bryan Cave LLP De-identification of data refers to the process used to prevent personal identifiers from being connected with information. The FTC indicated in its 2012 report Protecting Consumer Privacy in an Era of Rapid Change: Recommendations for Businesses and Policymakers that the FTC’s privacy framework only applies to data […]

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FDA-Related Issues Not to Miss in the New Cures Legislation

On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development and delivery” of innovative products, including by adding and modifying various programs administered by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the new legislation […]

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crossword puzzle indicates ebola vaccine is urgently needed to save lives of the infected

Recent Changes to the Orphan Drug Guidelines

The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years, a number of issues which challenge the current system have emerged, and […]

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