News & Views : New drug importation pathway, Digital Health center of excellence, ‘Intended Use’ clarification, Illegal opioid websites, Youth E-cig use trend, Collaborative communities, Promoting patient safety, Cannabis Drug Master Files – Drug and Device Digest

Importation of Certain FDA Approved Human Prescription Drugs, Including Biological Products, and Combination Products

Potential pathway for manufacturers to commercialize an FDA-approved drug originally intended to be marketed in a foreign country and authorized for sale in that foreign country

  • The final rule allows FDA-authorized programs to import certain prescription drugs from Canada
  • Under specific conditions to ensure no additional risk to the public’s health and safety
  • Could achieve significant reduction in the cost of covered products to the American consumer
  • Guidance provides procedures to interested manufacturers


New Digital Health Center of Excellence

Digital Health Center of Excellence for the advancement of digital health technology

  • Mobile health devices, Software as a Medical Device (SaMD), Wearables medical products
  • Centralized expertise and resource for digital health technologies and policy for digital health innovators, public, FDA staff
  • Goal: Advance health care by fostering responsible and high-quality digital health innovation
  • Objectives: Connect and build partnerships, Share knowledge,  Innovate regulatory approaches 
  • Bakul Patel appointed Director


Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

To clarify the regulatory language describing the types of evidence relevant to determining a product’s intended uses

  • Any relevant source of evidence may be considered
  • However, an unapproved use, standing alone, is not sufficient
  • Examples provided in Final Rule


FDA Warns Website Operators Illegally Selling Opioids to Consumers

Warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act

  • Sale without prescription
  • Lack adequate directions for use
  • Put consumers at risk of addiction, abuse and misuse
  • Can lead to overdose and death

Warning letters issued to:,,,,,,,,,,,,,, Thomas Meds,,


Encouraging Decline in Overall Youth E-Cigarette Use, However, concerning Uptick in Use of Disposable Products

New data from the 2020 National Youth Tobacco Survey (NYTS)

  • 1.8 million fewer U.S. youth currently using e-cigarettes compared to 2019
  • However, 3.6 million U.S. youth still use e-cigarettes – a public health crisis
  • Alarming uptick in use of disposable e-cigarettes (e.g. ENDS) by youth – 26.5% of high school and 15.2% of middle school students  
  • All new and existing tobacco products need to submit premarket application for FDA review for marketing authorization – DEADLINE 9/9
  • FDA will take action if products targeted to kids; warnings letters already already issued to some


Collaborative Communities: FDA Participates in 3 New Communities

Collaborative community is a private- and public-sector collaboration which can include the FDA

  • CDRH works together on medical device challenges to achieve common objectives and outcomes
  • Challenges are ill-defined or there is no consensus on the definition of the challenges
  • Challenges and outcomes are complex
  • Partners are interrelated
  • Incremental or unilateral efforts to address the challenge have been ineffective
  • Partners seek to optimize efforts, including preventing duplication of efforts
  • Better outcomes could be achieved with integrating different perspectives, experiences, resources, and expertise

Currently participates as a member of the five collaborative communities controlled by external stakeholders

  • Standardizing Laboratory Practices in Pharmacogenomics Initiative (STRIPE) 
  • International Liquid Biopsy Standardization Alliance (ILSA) 
  • Xavier Artificial Intelligence (AI) World Consortium


Efforts to Promote Patient Safety

Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality issued “Safer Together: A National Action Plan to Advance Patient Safety,” developed by the National Steering Committee (NSC) for Patient Safety. FDA actively involved with NSC.

4 approaches creating a culture of total systems safety

  • Culture, Leadership, and Governance: Commitments to safety as a core value
  • Patient and Family Engagement: Ensure meaningful partnership
  • Workforce Safety: Eliminate harm to both patients and the workforce
  • Learning System: Networked and continuous learning


Use of Drug Master Files to Further Support Cannabis Research  

Potential benefits of using Drug Master Files (DMFs) research on drugs containing cannabis and cannabis-derived compounds

  • Used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing
  • Allow 3rd parties to reference material (e.g., CMC) without disclosing DMF contents to those parties
  • Permits review of DMF information by FDA to support applications submitted by one or more applicants
  • DMF holder must provide a Letter of Authorization (LOA) and can have private agreements about information sharing, but FDA will not reveal any DMF contents to the applicant.


Image credits: FDA

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