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# OPQ Supported 55 Novel Drug Approvals in 2023
- URL: https://www.fdaweb.com/opq-supported-55-novel-drug-approvals-in-2023/
- Published: 2024-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:27:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156692

The CDER Office of Pharmaceutical Quality (OPQ) annual report for 2023 says it supported 55 novel drug approvals, including 17 biotechnology products. The [report](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTc3NDcwL2Rvd25sb2FkP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyNDA0MDMuOTI3ODk1MzEifQ.71g6ISrE23lv24zUMAKVPXa-kfG9qTYa%5F6K-R5xV3Og/s/1255931999/br/240048959216-l?ref=fdaweb.com) also credits OPQ with 359 expedited quality assessments to address drug shortages, 28 priority assessments to address orphan diseases, and 65 pre-license inspections in 10 states and 18 countries. Those accomplishments were listed under the OPQ Collaboration strategic priority. Other priorities and their accomplishments were:

- Communication
  - supported the release of 10 guidances;
  - published seven Manuals of Policy and Procedures and two compliance programs;
  - released the 6/2023 report on the State of Pharmaceutical Quality;
  - published more than 90 articles in peer-reviewed literature; and
  - participated more than 350 times in public workshops, conferences, and webinars;
- Engagement
  - developed 12 CDER workshops and events;
  - hosted the biennial Pharmaceutical Quality Symposium for nearly 7,000 virtual attendees from 122 countries;
  - developed seven international guidelines on quality topics;
  - evaluated two submissions alongside other global regulators in international pilot programs;
  - participated in 119 U.S. Pharmacopeia expert bodies; and
  - published two papers on Quality Management Maturity;
- Innovation
  - accepted 15 proposals to the Emerging Technology Program;
  - hosted a two-day public workshop and published a white paper on artificial intelligence in drug manufacturing;
  - published a paper summarizing the stakeholder feedback on the regulatory framework for distributed manufacturing;
  - hosted a public workshop supporting the 12/2023 release of a draft guidance on the Advanced Manufacturing Technologies Designation Program; and
  - Knowledge-aided Assessment and Structured Application streamlined the assessment of nearly 1,440 applications.