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Clinical Research
ICMEJ Proposes Data Socialism – Data Utopianism Has its Cracks –…
The International Committee of Medical Journal Editors (ICMJE) recently put forth a proposed set of new requirements for…
NIH Launches “ClinRegs” Website Aggregating Country-By-Country…
The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online…
European Medicines Agency Inching Towards Clinical Trial Transparency
The European Medicines Agency (EMA) Management Board has been inching towards a policy on clinical trial transparency.…
Clinical Trial Transparency Update: Eli Lilly, Bayer, Boehringer, and BMS…
Eli Lilly, Bayer Healthcare, and Boehringer Ingelheim have announced their plans to increase access to their clinical trial…
World Congress Second Annual Medical Affairs Summit
Transparency requirements and other regulatory initiatives have affected all aspects of healthcare delivery. Medical Affairs and…
Pharmaceutical Companies Moving Towards Greater Clinical Trial Transparency
The Centers for Medicare and Medicaid (CMS) released all of its Medicare billing data for individual physicians last week. The…
FDA Draft Guidance Analgesic Indications: Developing Drug and Biological…
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop…
European Union Agrees to Harmonize Clinical Trial Requirements
Recently, the Committee of Permanent Representatives (COREPER I) the Member States endorsed the agreement reached by the…
Physician Payment Sunshine Act: Clinical Research Professionals Concerned…
In our continuing coverage of the Physician Payment Sunshine Act, we turn our attention to an article authored by Gary A.…
Increased Clinical Trial Transparency in US and Abroad
Over the past several months, the European Medicines Agency (EMA) has been focusing on making the results and data of clinical…