PackagesCanonicalsLogsProblems
    Packages
    hl7.fhir.us.pq-cmc-fda

hl7.fhir.us.pq-cmc-fda

Install package
npm install --registry https://fs.get-ig.org/pkgs hl7.fhir.us.pq-cmc-fda
Get resources
curl https://fs.get-ig.org/rs/hl7.fhir.us.pq-cmc-fda-2.0.0-ballot.ndjson.gz | gunzip | jq '{url,resourceType,version, id}'

The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Thu, Dec 12, 2024 18:53+0000+00:00)

package.json
{
  "description": "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Thu, Dec 12, 2024 18:53+0000+00:00)",
  "fhirVersions": [ "5.0.0" ],
  "tools-version": 3,
  "_id": "hl7.fhir.us.pq-cmc-fda@2.0.0-ballot",
  "date": "20241212185304",
  "license": "CC0-1.0",
  "jurisdiction": "urn:iso:std:iso:3166#US",
  "dist": {
    "tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-2.0.0-ballot.tgz"
  },
  "name": "hl7.fhir.us.pq-cmc-fda",
  "dist-tags": {
    "latest": "2.0.0-ballot"
  },
  "type": "IG",
  "title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
  "author": "HL7 International / Biomedical Research and Regulation",
  "_versions": [ "2.0.0-ballot", "1.0.0", "1.0.0-ballot" ],
  "id": "hl7.fhir.us.pq-cmc-fda@2.0.0-ballot",
  "directories": {
    "lib": "package",
    "example": "example"
  },
  "canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/2025Jan",
  "versions": {
    "1.0.0": {
      "description": "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Wed, Dec 11, 2024 13:39+0000+00:00)",
      "fhirVersions": [ "5.0.0" ],
      "tools-version": 3,
      "_id": "hl7.fhir.us.pq-cmc-fda@1.0.0",
      "date": "20241211133926",
      "license": "CC0-1.0",
      "jurisdiction": "urn:iso:std:iso:3166#US",
      "dist": {
        "tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-1.0.0.tgz"
      },
      "name": "hl7.fhir.us.pq-cmc-fda",
      "type": "IG",
      "title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
      "author": "HL7 International / Biomedical Research and Regulation",
      "id": "hl7.fhir.us.pq-cmc-fda@1.0.0",
      "directories": {
        "lib": "package",
        "example": "example"
      },
      "canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/STU1",
      "version": "1.0.0",
      "maintainers": [ {
        "url": "http://www.hl7.org/Special/committees/rcrim",
        "name": "HL7 International / Biomedical Research and Regulation",
        "email": "brr@lists.HL7.org"
      } ],
      "dependencies": {
        "hl7.terminology.r5": "6.1.0",
        "hl7.fhir.uv.extensions.r5": "5.1.0"
      }
    },
    "1.0.0-ballot": {
      "description": "The FDA PQ-CMC FHIR IG  is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Mon, Apr 8, 2024 17:45+0000+00:00)",
      "fhirVersions": [ "5.0.0" ],
      "tools-version": 3,
      "_id": "hl7.fhir.us.pq-cmc-fda@1.0.0-ballot",
      "date": "20240408174517",
      "license": "CC0-1.0",
      "dist": {
        "tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-1.0.0-ballot.tgz"
      },
      "name": "hl7.fhir.us.pq-cmc-fda",
      "type": "IG",
      "title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
      "author": "HL7 International / Biomedical Research and Regulation",
      "id": "hl7.fhir.us.pq-cmc-fda@1.0.0-ballot",
      "directories": {
        "lib": "package",
        "example": "example"
      },
      "canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/2024May",
      "version": "1.0.0-ballot",
      "maintainers": [ {
        "url": "http://www.hl7.org/Special/committees/rcrim",
        "name": "HL7 International / Biomedical Research and Regulation",
        "email": "brr@lists.HL7.org"
      } ],
      "dependencies": {
        "hl7.terminology": "5.5.0",
        "hl7.fhir.uv.extensions.r5": "1.0.0"
      }
    },
    "2.0.0-ballot": {
      "description": "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Thu, Dec 12, 2024 18:53+0000+00:00)",
      "fhirVersions": [ "5.0.0" ],
      "tools-version": 3,
      "_id": "hl7.fhir.us.pq-cmc-fda@2.0.0-ballot",
      "date": "20241212185304",
      "license": "CC0-1.0",
      "jurisdiction": "urn:iso:std:iso:3166#US",
      "dist": {
        "tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-2.0.0-ballot.tgz"
      },
      "name": "hl7.fhir.us.pq-cmc-fda",
      "type": "IG",
      "title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
      "author": "HL7 International / Biomedical Research and Regulation",
      "id": "hl7.fhir.us.pq-cmc-fda@2.0.0-ballot",
      "directories": {
        "lib": "package",
        "example": "example"
      },
      "canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/2025Jan",
      "version": "2.0.0-ballot",
      "maintainers": [ {
        "url": "http://www.hl7.org/Special/committees/rcrim",
        "name": "HL7 International / Biomedical Research and Regulation",
        "email": "brr@lists.HL7.org"
      } ],
      "dependencies": {
        "hl7.terminology.r5": "6.1.0",
        "hl7.fhir.uv.extensions.r5": "5.1.0"
      }
    }
  },
  "version": "2.0.0-ballot",
  "maintainers": [ {
    "url": "http://www.hl7.org/Special/committees/rcrim",
    "name": "HL7 International / Biomedical Research and Regulation",
    "email": "brr@lists.HL7.org"
  } ],
  "dependencies": {
    "hl7.terminology.r5": "6.1.0",
    "hl7.fhir.uv.extensions.r5": "5.1.0"
  }
}

Versions