ESMO, FDA meetings and decisions

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for June 29-July 5, 2020. Take a break from the news — coronavirus and otherwise – and enjoy the Fourth of July holiday. Parades may be canceled, but an outdoor family picnic might be safe.

Anesthesiology: The FDA is expected to make a decision by July 5 on an ultra-short-acting and reversible anesthetic (Acacia Pharma’s Byfavo, remimazolam) for use in surgery and other invasive procedures. The PDUFA date was extended three months from April 5 after the company submitted additional data.

Oncology: The virtual ESMO World Congress on Gastrointestinal Cancer will take place July 1-4. The program focuses on practice-changing findings and new treatment approaches of interest to the global gastrointestinal cancer community.

Regulatory

  • The FDA is holding a virtual public meeting on June 30 on modernizing its data strategy. As the Agency prepares its Technology Modernization Action Plan (TMAP), it wants input on approaches to data quality, data stewardship, data exchange, and data analytics.
  • The FDA’s Center for Drug Evaluation and Research (CDER) is hosting a webinar on June 30 on the role of FDA and the Institute for Safe Medication Practices (ISMP) in preventing medication errors. The webinar will illustrate how information from ISMP’s National Medication Errors Reporting Program is shared with FDA to benefit overall drug safety.
  • The FDA’s Center for Devices and Radiological Health (CDRH) is hosting a virtual town hall on July 1 on immediately-in-effect guidance on Covid-19 diagnostic tests.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 148

Topic ID: 88,148,663,730,697,935,192,148,150,725