ONDQA

Acronym	Definition
ONDQA	Office of New Drug Quality Assessment (Federal Drug Administration; US)

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Also, regulators have been invited from FDA and MHRA, Center for Biologics Evaluation and Research (CBER), Office of Biotechnology Products (OBP), Office of Compliance (OC), Office of New Drug Quality Assessment (ONDQA), Office of Generic Drugs (OGD).

ISPE meeting heads to the capitol: explore industry challenges and opportunities

Deficiencies in New Drug Applications Aloka Srinivasan, Office of Generic Drugs, CDER, FDA; Robert Iser, Office of Generic Drugs, CDER, FDA & Richard Lostritto, Director of Division-III, Office of New Drug Quality Assessment (ONDQA), FDA

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If a company has questions regarding whether a specific change requires a supplement or may be included in the annual report, CDER directs them to the appropriate review division in the Office of New Drug Quality Assessment (ONDQA), Office of Generic Drugs (OGD), or New Drug Microbiology Staff (OPS-NDMS).

Draft guidance document for industry: CMC postapproval manufacturing changes reportable in annual reports

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