August 2018 – Drug and Device Digest

News and Views: Evidence based prescription opioids, Additional tropical diseases for PRV, Quality Metrics Site Visit Program, Placebo controlled oncology clinical trials


New steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

Need to reexamine how opioid analgesics are being prescribed

  • Arm health care providers with the most current and comprehensive guidance on  appropriate pain management
  • Work together with medical professional societies to develop  evidence-based guidelines

Contract with National Academies of Sciences, Engineering, and Medicine (NASEM)

  • Advance development of evidence-based guideline and understand needed evidence
  • Identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed
  • Scan existing opioid analgesic prescribing guidelines, how developed, gaps in evidence
  • Outline research needed to generate that evidence
  • Meetings and public workshops with broad range of stakeholders



FDA Adds Four Tropical Diseases to Priority Review Voucher (PRV) Program to Encourage Development

Addition of: 

  • Lassa fever
  • Chikungunya virus disease
  • Rabies
  • Cryptococcal meningitis

Applicants who submit drug/biological products applications may qualify for a  Priority Review Voucher (PRV)

  • Can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review




Quality Metrics Site Visit Program for CDER & CBER; Information Available to Industry; Extension of the Proposal Period

Quality Metrics Site Visit Program for FDA staff involved in development of FDA’s Quality Metrics Program

  • Gain exposure to robust quality metrics programs
  • Through on-site visits, tours of operations, discussions
  • Observe how quality metrics data are gathered, collected, reported to management

The intended timeframe of the on-location Quality Metrics site visits is from October 1, 2018 to  September 30, 2019



Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Placebo-controlled design only in selected circumstances

  • where surveillance is standard of care
  • with certain trial design features (e.g. if the trial uses an add-on design, when the
    endpoint intended to support a labeling claim has a high degree of subjectivity, such as patient reported outcomes


  • Rationale for the trial design
  • Justification in the setting of  sham surgical procedure or when invasive methods required for administration of the placebo (e.g., intrathecal administration, repeated 78 intravenous administration via an indwelling catheter)
  • No requirement of  patient-level maintenance of blinding at time of disease
  • Unblinding patient at time of documented disease recurrence or progression to ensure optimal patient management


Image credit: FDA

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