Regulatory Insights

  1. The Sunshine Act - It's Finally ‘Official’

    So now that the long wait is over for the final rule, where do you go from here? On February 8th, 2013 the final rule of the Physician Payment Sunshine Provision (PPSP aka "Sunshine Act") was released by The Centers for Medicare and Medicaid Services (CMS). By Kevin Williams

  2. 5 Reasons To Synergize CTA Negotiations And Essential Document Collection

    The contractual and regulatory landscapes are ever-changing, increasingly complex and study timelines just keep getting shorter. By Rebecca Arch

  3. Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety

    Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo

  4. MHRA’s Summary Of PV Systems (SPS) Document

    As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert

  5. MHRA’s Compliance Report

    On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert

  6. Don’t Take It For Granted

    Investigator grant payments are typically the single greatest expense in a clinical trial budget, often accounting for 40 to 60 per cent of the total budget. By Kevin Williams, CFS Clinical

  7. CFS Clinical Helps Top 20 Pharma Improve Investigator Payment And Budget Management While Addressing Sunshine & FMV Compliance

    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. Presented By Jim DiCesare, VP and General Manager, Contract and Regulatory Services

  8. FDA Encourages More Women in Clinical Trials

    The FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.

  9. Managing Clinical Risk For The Development Of Drugs And Devices

    Managing regulatory risk in an environment of increasing regulatory scrutiny is a critical success factor to consistently develop and launch new products efficiently. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of clinical development through a review of regulatory trends for a period of 18 months.

  10. Drug Safety In France & Underreporting Of AEs

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