News and Views: Digital Health Innovation, Development of New Antibacterial Drugs, Opioid REMS, Civil Money Penalties Related to – Drug and Device Digest


Efforts to work with tech industry to spur innovation in digital health


Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria

Bacterial drug resistance is major threat to public health
  • Design and conduct of clinical trials to evaluate new antibacterial drugs challenging
  • Recruitment can be difficult
  • Delay in availability of information regarding identification and antibacterial susceptibility of the causal pathogen
Request for Information (RFI) to solicit input from public and private sectors into developing regulatory science initiatives specific for antimicrobial products


Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Approval of final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

  • Several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals
  • Applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting
  • Also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012

New requirements

  • Training for health care providers who are involved in the management of patients with pain, and not only to prescribers
  • Education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain
  • New product labeling containing information about the health care provider education

New FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint)

  • Updated educational content
  • Ensure proper product is selected for the patient and used with appropriate clinical oversight



Civil Money Penalties Relating to the Data Bank

Describes civil money penalties against responsible parties and/or submitters on submission of regiatration and /or results information to the data bank and/or certain certifications to FDA

  • How do the Centers intend to identify whether
    • responsible parties have failed to submit required clinical trial registration and/or results information to the data bank
    • Submitted false or misleading information to the data bank
    • Failed to submit to FDA the certification
  • Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
  • What procedures apply when a Center seeks civil money penalties?
  • What civil money penalty amounts may be assessed


Image credit: FDA

Scroll to Top