This is an interesting topic for which several confusing points have arisen and which merits an in depth look. By Bart Cobert
This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert
Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. By CFS Clinical
Continuing with the review of the key points in FDA’s guidance. This is the second of three postings. By Bart Cobert
Continuing with the review of the key points in FDA’s guidance. This is the final part. By Bart Cobert
FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. By Bart Cobert
In December 15, 2012 FDA issued its updated Chapter 53 on Postmarketing Adverse Drug Experience (PADE) Reporting Instructions. This is part of FDA’s Compliance Program Guidance Manual but is, in reality, more or less an SOP for FDA’s inspectors. By Bart Cobert
In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert
The Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research
The FDA is encouraging electronic source data for clinical investigations. This presentation looks at the intentions of the guidance, related regulations and guidelines, understanding new clarified definitions, and what this new guidance means to DATARAK and other EDC vendors being eSource compliant.
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