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Clinical Research
FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective…
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for…
ASCO Removes Restrictions on Researchers’ Conflict of Interest
The American Society of Clinical Oncology (ASCO) has removed all restrictions on author relationships previously in the 2013…
CME Outcomes Increase with Local Participation in Content
Teams from Rockpointe and Potomac Center for Medical Education worked together to draft an article recently published in the…
PhRMA Members Invested $58.8 Billion in R&D in 2015
In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is…
NIH Asks for Input on NCAB Cancer Moonshot Blue Ribbon Panel
Recently, the National Institutes of Health (NIH) released a Request for Information (RFI), asking for both public and…
FDA Guidance: Determining the Extent of Safety Data Collection Needed in…
The FDA finalized a guidance it originally released in 2012 that is aimed to help industry collect safety data in…
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.…