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).
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
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).