3.1 FDA approval processes for drugs and devices

The FDA approval process is a crucial step in bringing new drugs and medical devices to market. It involves rigorous testing, extensive data collection, and thorough review to ensure safety and efficacy. Different pathways exist for various types of products, from standard applications to expedited programs for urgent medical needs.

For drugs, the process includes clinical trials and New Drug Applications. Medical devices follow either the Premarket Approval or 510(k) clearance route, depending on their risk classification. Both processes aim to protect public health while promoting innovation in healthcare.

Drug Approval Process

New Drug Application and Investigational New Drug

Top images from around the web for New Drug Application and Investigational New Drug

• 

  Frontiers | Determining the Balance Between Drug Efficacy and Safety by the Network and ... View original

  Is this image relevant?

• 

  Food and Drug Administration - Rx-wiki View original

  Is this image relevant?

• 

  Drug Discovery Enhanced by Artificial Intelligence | Biomedres View original

  Is this image relevant?

• 

  Frontiers | Determining the Balance Between Drug Efficacy and Safety by the Network and ... View original

  Is this image relevant?

• 

  Food and Drug Administration - Rx-wiki View original

  Is this image relevant?

1 of 3

Top images from around the web for New Drug Application and Investigational New Drug

• 

  Frontiers | Determining the Balance Between Drug Efficacy and Safety by the Network and ... View original

  Is this image relevant?

• 

  Food and Drug Administration - Rx-wiki View original

  Is this image relevant?

• 

  Drug Discovery Enhanced by Artificial Intelligence | Biomedres View original

  Is this image relevant?

• 

  Frontiers | Determining the Balance Between Drug Efficacy and Safety by the Network and ... View original

  Is this image relevant?

• 

  Food and Drug Administration - Rx-wiki View original

  Is this image relevant?

1 of 3

• New Drug Application (NDA) serves as formal request to FDA for approval to market a new drug
• NDA contains comprehensive data on drug safety, efficacy, and manufacturing processes
• Investigational New Drug (IND) application precedes NDA, allows clinical trials to begin
• IND includes preclinical data, manufacturing information, and clinical protocols
• CDER (Center for Drug Evaluation and Research) reviews NDAs and INDs
• CDER evaluates drug safety, efficacy, and quality to determine approval status

Clinical Trials and Approval Pathways

• Clinical trials consist of three main phases to test drug safety and efficacy
  • Phase I: Small group of healthy volunteers to assess safety and dosage
  • Phase II: Larger group of patients to evaluate effectiveness and side effects
  • Phase III: Large-scale trials to confirm safety and efficacy in diverse populations
• Orphan drug designation granted for drugs treating rare diseases (fewer than 200,000 patients in US)
  • Provides incentives like tax credits and extended market exclusivity
• Fast track designation expedites review of drugs for serious conditions with unmet medical needs
  • Allows for rolling review of NDA sections as they are completed
• Breakthrough therapy designation accelerates development of drugs showing substantial improvement over existing therapies
  • Intensive FDA guidance and organizational commitment provided

Expedited Review Programs

• Accelerated approval pathway based on surrogate endpoints or intermediate clinical endpoints
  • Allows earlier approval for drugs treating serious conditions
  • Requires post-approval confirmatory trials to verify clinical benefit
• Priority review designation shortens FDA review time from 10 months to 6 months
  • Granted for drugs offering significant improvements in safety or effectiveness
• These expedited programs aim to bring important new drugs to market faster
  • Address unmet medical needs for serious conditions (cancer, HIV/AIDS)

Medical Device Approval Process

Premarket Approval (PMA) for Class III Devices

• Premarket Approval (PMA) required for Class III medical devices (highest risk)
• PMA process involves rigorous scientific and regulatory review to ensure safety and effectiveness
• Applicants must provide comprehensive clinical trial data and manufacturing information
• FDA may convene advisory panel of experts to review PMA application
• PMA approval grants permission to market the device in the United States
• Post-approval studies often required to monitor long-term safety and effectiveness

510(k) Clearance for Class I and II Devices

• 510(k) clearance pathway used for Class I and II medical devices (lower risk)
• Demonstrates device is substantially equivalent to a legally marketed predicate device
• Substantial equivalence means similar intended use and technological characteristics
• 510(k) submission typically requires less clinical data than PMA
• FDA reviews 510(k) submissions within 90 days to determine substantial equivalence
• Cleared devices can be marketed without further regulatory requirements

CDRH Oversight and Device Classification

• CDRH (Center for Devices and Radiological Health) oversees medical device regulation
• Responsible for evaluating PMAs, 510(k) submissions, and other device applications
• Classifies medical devices into three categories based on risk and regulatory controls needed
  • Class I: Low risk (dental floss, bandages)
  • Class II: Moderate risk (powered wheelchairs, infusion pumps)
  • Class III: High risk (implantable pacemakers, breast implants)
• CDRH conducts post-market surveillance to monitor device safety and effectiveness
• Implements recalls and other corrective actions when safety issues arise