Regulatory Insights

  1. Drug Safety In France & Underreporting Of AEs
    2/12/2013

    There is a lively controversy underway in France right now regarding drug safety. By Bart Cobert

  2. Challenges, Prechallenges, Dechallenges And Rechallenges
    2/12/2013

    This is an interesting topic for which several confusing points have arisen and which merits an in depth look. By Bart Cobert

  3. Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees
    2/12/2013

    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

  4. Improve Investigator Payment and Budget Management While Addressing Sunshine & FMV Compliance
    2/11/2013

    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

  5. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II
    1/22/2013

    Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings. By Bart Cobert

  6. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part III
    1/22/2013

    Continuing with the review of the key points in FDA’s guidance. This is the final part. By Bart Cobert

  7. FDA’s December 2012 Guidance On IND And BA/BE Reporting – Part I
    1/9/2013

    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

  8. FDA’s SOP For FDA’s PV Inspectors
    1/8/2013

    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

  9. Source Documents And Data Retention In Drug Safety
    12/20/2012

    In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert

  10. The Sunshine Act: Physician Payment Sunshine Provisions
    12/18/2012

    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