Week of Nov 27, 2017


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CDER Conversation: The FDA’s Sentinel Initiative

The Sentinel Initiative is national electronic system that monitors safety of marketed drugs, vaccines, biologics and medical devices

  • Includes Active Risk Identification and Analysis (ARIA) system
  • 17 data partners such as insurance companies, HMOs, and hospitals
  • Access to 223 million members
  • Data derived from administrative claims databases that healthcare insurers use for reimbursement for diagnoses, procedures, and medications
  • Used as a resource for new product reviews

Sentinel System different from other systems 

  • Distributed data approach – data partners maintain physical and operational control over electronic data using Sentinel Common Data Model
  • Secure access to multiple data sources to achieve far larger sample sizes
  • Allow data aggregation while safeguarding patient privacy
  • Routine Querying Tools

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FDA, International Regulators Look at Common Challenges, ‘Innovation’

 Global regulatory experts from 28 countries, including FDA, discussed ‘Innovation’ issues of mutual concern

  • regenerative medical products
  • international collaboration to fight antimicrobial resistance (AMR)
  • developing strategies to combat substandard or falsified medical products

FDA presentations

  • Use of real world evidence (RWE) in pre- and post-market activities
  • Align their approaches to the evaluation of antibiotics
  • Working with WHO in combating falsified/substandard medical products
  • Need for international cooperation and increased sharing of inspectional results, collaborating on pharmacovigilance needs, and advancing regulatory science

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PEPFAR: FDA Approves 200th HIV/AIDS Therapy

FDA tentatively approved  the 200th antiretroviral drug application under the President’s Emergency Plan for AIDS Relief (PEPFAR)

  • PEPFAR launched in 2003 to address global HIV/AIDS epidemic by stimulating  development of new HIV therapies
  • FDA used guidance, outreach and expedited review process
  • FDA encouraged submission for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies

Advancements to facilitate treatment in areas of the world lacking advanced health care infrastructure, particularly in parts of Africa 

  • FDC even in circumstances with patent or exclusivity market protection for one or more of the components in the U.S
  • Due to the significant public health impact of these products, FDA prioritized review
  • Products purchased with U.S. funds under the President’s PEPFAR Fund

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FDA ushering in new era of 3D printing of medical products

FDA has reviewed >100 3D printed devices currently on the market

  • Patient-matched devices tailored to fit patient’s anatomy – knee replacements, implants
  • Drug produced on 3D printer with more porous matrix
  • Envision 3D printed new skin cells for burn wounds

State-of-the-art 3D printing facilities on FDA campus

  • CDER scientists determine how 3D drug printing impacts manufacturing
  • CDRH scientists investigate the effect of design changes on device performnace
  • Understand policy framework to ensure quality and safety of 3D printed products

Providing comprehensive policy framework to manufacturers

  • CDER’s Emerging Technology Program
  • New guidance on technical aspects of 3D printing (additive manufacturing)
  • Review regulatory issues related to bioprinting of biological, cellular and tissue-based product

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Image credits: FDA, PEPFAR

 

 

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