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The Office of Pharmaceutical Quality published its 2017 Annual Report highlighting accomplishments such as the approval of: ● 132 new drug applications, including 13 breakthrough therapies ● 1,027 generic drug applications, including 150 priority first generics, and ● 21 biologics applications, including seven breakthrough therapies and five biosimilars.
The report also elaborated on key OPQ 2017 initiatives, such as their agreement with CDER and ORA on a concept of operations (ConOps) integrating facility evaluation and inspection, and a list of 2017 guidance documents and MAPPS. In 2017, 139 courses and seminars in support of scientific and regulatory education and professional development were delivered, and OPQ authors contributed to over 150 peer-reviewed articles.
This year, OPQ plans to roll out a 2018–2022 Strategic Plan, which will include strategic priorities, objectives, and performance goals to guide OPQ over a 5-year period.[/membership]