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Voluntary Consensus Standards to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

Recognizing “voluntary consensus standards” based on nationally and internationally accepted standards for drug quality

  • New draft guidance  to propose pharmaceutical quality standards for potential recognition by the FDA, providing industry with additional options for pharmaceutical development and manufacturing
  • Promote and expedite  development, streamline FDA review of drug product applications
  • Provide list of recognized standards on website; reduce regulatory uncertainty

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Efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

Efforts to stopping spread of illicit opioids and  securing all aspects of supply chain

  • Enforcement and interdiction of illegal shipment through US Postal Services
  • Work closely with U.S. Customs and Border Protection and U.S. Department of Justice
  • Warning Letters for illegal online marketing
  • Online Opioid Summit with appropriate stakeholders for stronger action
  • Warning letter under the Drug Supply Chain Security Act (DSCSA) McKesson Corp
  • New guidances
    • Risk/benefit framework to opioid analgesics including illicit use risks
    • Modernize development pathway for non-opioid analgesics for specific clinical conditions
    • Packaging requirements to limit number with single prescription
  • Continue work in accordance with Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

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Nonbinding Feedback after Certain FDA Inspections of Device Establishments

Standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests

  • Request for nonbinding feedback submitted by device establishment to FDA regarding firm’s proposed actions to address Form 483 inspectional observations

Firm’s proposals for addressing Inspectional Observations related to

  • release of violative product that may cause death or serious injury
  • production of nonconforming, violative, and/or defective finished devices
  • release of devices likely to cause 196 death or serious injury

FDA informal feedback on whether proposals

  • address inspectional observations
  • partially adequate or inadequate with explanation
  • recommend what may be needed to be adequate

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Capture.JPGNew approach for understanding Ebola Virus Pathogenesis

Contract with Broad Institute to conduct the largest Ebola virus and host gene expression (i.e., transcriptomics) study

  • Assess how Ebola virus evolves and spreads within the body
  • Identify mechanisms and biological pathways altered in immune cells and tissues during infection
  • Inform natural history of Ebola virus disease in humans
  • Characterize nonclinical models necessary for testing
  • Utilize fordeveloping medical countermeasures (MCMs) to prevent and treat Ebola virus disease

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Image credit: FDA

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