Session 10: US Regulatory and Policy Updates: FDA and ClinicalTrials.gov Developments
Suzanne Carlson, MA
ABSD Associates, LLC, United States
In 2018, the FDA issued a draft guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank, meant to address how violations of the requirements of the Final Rule would be identified, under what circumstances civil monetary penalties would be sought, what procedures would apply, and what penalty amounts would be assessed. In 2019, as part of the FDA‘s assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process for drug and biological products, the agency issued a Federal Register notice to open a docket for public comment on the Clinical Data Summary Report Pilot Program, as well as a new integrated review of marketing applications process and documentation template. Also in 2019, the U.S. Supreme Court reversed and remanded a lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government, thus impacting the government’s stance on transparency and disclosure, an important ruling for FDA-regulated companies who are required to submit commercial information to the Agency. This session will explore these recent developments in the US, and provide a regulatory and policy update from ClinicalTrials.gov.
ClinicalTrials.gov Civil Money Penalty Draft Guidance: Patrick McNeilly, PhD
Senior Health Policy Analyst, Office of Special Medical Programs, OC
FDA, United States
ClinicalTrials.gov Program Updates : Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert
Essex, A Veridix AI Company, United States
FDA Federal Register Notice New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication – PhRMA’s Perspective: Olivia Shopshear, MS
Senior Director, US Regulatory Policy Lead
Biogen, United States
Secret Keeper: Do Harry Potter and the FDA Have Similar Powers?: Anne K. Walsh, JD
Hyman, Phelps & McNamara, PC, United States
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