{
  "_type": "curated_open_data",
  "as_of": "2026-07",
  "links": {
    "canonical": "https://verticalmarketplace.ai",
    "docs_for_llms": "https://verticalmarketplace.ai/llms.txt",
    "sell_your_own": "https://verticalmarketplace.ai/api/marketplace/listings",
    "vertical_listings": "https://verticalmarketplace.ai/api/marketplace/listings?vertical=pharma"
  },
  "records": [
    {
      "item": "New Drug Application (NDA)",
      "source": "FDA",
      "category": "pathway",
      "definition": "Application to market a new brand-name drug",
      "statutory_reference": "Section 505(b) of the Federal Food, Drug, and Cosmetic Act"
    },
    {
      "item": "Abbreviated New Drug Application (ANDA)",
      "source": "FDA",
      "category": "pathway",
      "definition": "Application to market a generic version of an approved drug",
      "statutory_reference": "Hatch-Waxman Amendments of 1984"
    },
    {
      "item": "Biologics License Application (BLA)",
      "source": "FDA",
      "category": "pathway",
      "definition": "Application to market a biological product",
      "statutory_reference": "Section 351 of the Public Health Service Act"
    },
    {
      "item": "505(b)(2) application",
      "source": "FDA",
      "category": "pathway",
      "definition": "Hybrid application relying in part on data the applicant did not generate",
      "statutory_reference": "Section 505(b)(2) of the FD&C Act"
    },
    {
      "item": "Priority review",
      "source": "FDA",
      "category": "timeline",
      "definition": "Faster review for drugs that offer significant improvements",
      "statutory_reference": "PDUFA goal of about 6 months after filing"
    },
    {
      "item": "Standard review",
      "source": "FDA",
      "category": "timeline",
      "definition": "Default review track for applications",
      "statutory_reference": "PDUFA goal of about 10 months after filing"
    },
    {
      "item": "Breakthrough therapy designation",
      "source": "FDA",
      "category": "expedited program",
      "definition": "Designation expediting drugs showing substantial early improvement",
      "statutory_reference": "Created by FDASIA in 2012"
    },
    {
      "item": "Fast track designation",
      "source": "FDA",
      "category": "expedited program",
      "definition": "Facilitates development of drugs treating serious conditions with unmet need",
      "statutory_reference": "FDA Modernization Act of 1997"
    },
    {
      "item": "Accelerated approval",
      "source": "FDA",
      "category": "expedited program",
      "definition": "Approval based on a surrogate endpoint likely to predict clinical benefit",
      "statutory_reference": "Established by regulation in 1992"
    },
    {
      "item": "Orphan drug designation",
      "source": "FDA",
      "category": "incentive",
      "definition": "Incentives for drugs treating rare diseases",
      "statutory_reference": "Orphan Drug Act of 1983; U.S. prevalence under 200,000"
    },
    {
      "item": "Recall Class I",
      "source": "FDA",
      "category": "recall class",
      "definition": "Reasonable probability of serious harm or death",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "Recall Class II",
      "source": "FDA",
      "category": "recall class",
      "definition": "Temporary or medically reversible harm is possible",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "Recall Class III",
      "source": "FDA",
      "category": "recall class",
      "definition": "Unlikely to cause harm but violates FDA rules",
      "statutory_reference": "FDA recall classification"
    },
    {
      "item": "CDER novel drug approvals in 2023",
      "source": "FDA CDER",
      "category": "statistic",
      "definition": "Count of novel drugs approved by the Center for Drug Evaluation and Research",
      "statutory_reference": "55 novel drugs approved in 2023"
    }
  ],
  "sources": [
    {
      "url": "https://www.fda.gov/drugs/development-approval-process-drugs",
      "name": "FDA — Development & Approval Process (Drugs)"
    },
    {
      "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls",
      "name": "FDA — Drug Recalls"
    }
  ],
  "category": "benchmarks",
  "vertical": "pharma",
  "data_note": "All records are public-domain facts compiled from the cited sources as of the asOf date. This content is authored and served by the platform itself — it is not seller data, so the marketplace's zero-storage promise about seller datasets is unaffected.",
  "record_count": 14,
  "what_this_is": "A platform-published open-data listing curated by Open Data Desk, the marketplace's in-house public-data seller. It is real free inventory: it counts in marketplace statistics and is purchasable for $0 through the normal purchase flow, which delivers this payload with an Ed25519-signed receipt.",
  "record_schema": {
    "item": "Pathway, program, timeline, or recall class",
    "source": "Publishing authority",
    "category": "Type of fact",
    "definition": "What it means",
    "statutory_reference": "The statute, program, or reference basis"
  },
  "buyer_use_cases": [
    "Ground regulatory strategy in exact approval-pathway definitions",
    "Explain review timelines and recall classes to non-specialist stakeholders",
    "Give market-access and pharmacovigilance teams a citable FDA fact base"
  ]
}