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Clinical Research
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FDA Draft Guidance Analgesic Indications: Developing Drug and Biological…
The FDA recently released a new draft guidance with recommendations on how sponsors of analgesic painkillers should develop…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…
JAMA Drops Requirement for Independent Statistical Analysis for Industry…
The Journal of American Medical Association dropped its requirement for independent statistical analyses of industry-funded…
GSK Opens Patient Level Data and Clinical Study Reports Available to…
Late last year, we reported that GlaxoSmithKline promised to make detailed data from its clinical trials available to independent…
GSK and other Pharmaceutical Companies Prepare to Release Global Patient…
“In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed…