FDA BRIEF: Week of September 25, 2017


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FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online

Operation Pangea X, a global cooperative effort led by Interpol, to combat unlawful sale and distribution of illegal, counterfeit, substandard medical products on the internet

  • Action against > 500 websites illegally selling dangerous, unapproved versions of prescription medicines –  including opioids
  • Remove products from supply chain
  • Prevent health risks as well as credit card fraud, identity theft and computer viruses

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How Patient Preferences Contribute to Regulatory Decisions for Medical Devices

Examples of using Patient Preference Initiative as part of medical device regulatory decision-making process

  • Expanded indication for home hemodialysis machine to be used without presence of care partner
  • Worked with medical device company, NxStage, to develop Patient Preference Framework
  • Enhancing safety of continuous glucose monitors – Dexcom G5 Continuous Glucose Monitoring (CGM) System and Animas Vibe System.
  • Used patient feedback to develop risk mitigation strategies such as lockout feature to prevent accidental boluses

Companies invited to discuss on patient preference information during Pre-Submission meetings

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FDA selects participants for new digital health software Precertification pilot program

Selection of companies to participate in a first-of-its kind pilot program to revolutionize digital health regulation in the U.S.

  • Pre-cert pilot program is precertify software developers based on systems for software design, validation and maintenance, meeting quality standards
  • Precertified companies could potentially submit less FDA information before marketing a new digital health tool
  • >100 applicants; selection based on company size, demonstrated record of quality and organizational excellence, represent unique approaches  digital health technology development

Apple, Cupertino, California

Fitbit, San Francisco, California

Johnson & Johnson, New Brunswick, New Jersey

Pear Therapeutics, Boston, Massachusetts

Phosphorus, New York, New York

Roche, Basel, Switzerland

Samsung, Seoul, South Korea

Tidepool, Palo Alto, California

Verily, Mountain View, California

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CapturePatents and Exclusivities for Generic Drug Products

Patent:

  • Property right granted by US -PTO -term of 20 years from the date of filing with the PTO
  • FDA does not enforce patents, or evaluate patent validity or infringement
  • Product manufacturers submit patent information to FDA for inclusion in “Orange Book”  –  informs when a generic drug application may be approved

Exclusivity:

  • Provides limited market protection from new competition; precludes approval of certain ANDAs for prescribed periods of time – Hatch Waxman Amendments
  • Also for brand-name “orphan” drug products- Orphan Drug Act
  • Also for certain pediatric-related uses and for qualifying antibiotic drug products.
  • FDA administers exclusivities

Types of Exclusivities:

  • Five-Year New Chemical Entity
  • Three-Year New Clinical Studies
  • Orphan Drug.
  • Pediatric
  • “Generating Antibiotic Incentives Now” (GAIN)
  • 180-Day

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New efforts to encourage compounding of better quality drugs 

Important for health care providers to have access to compounded drugs

  • When patient needs cannot be met by FDA-approved drugs
  • Oversight based on Drug Quality and Security Act (DQSA) to prevent manufacturing issues and associated patient risks
  • Posting  new report  on drugs that entities registered as outsourcing facilities have produced
  • Sharing guide, “Outsourcing Facility Information,” for outsourcing facilities
  • Collaboration with state partners at sixth intergovernmental meeting on drug compounding
  • Assist more compounders register as outsourcing facilities

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Image credits: FDA

 

 

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