Biomaterial Database

Scientific Considerations for Stability Studies of Drug Substances Supporting Abbreviated New Drug Applications (ANDAs). 2022

Jizhou Wang, and Neeru Takiar

Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration, 10903 South New Hampshire Ave, Silver Spring, Maryland, 20993, USA. jizhou.wang@fda.hhs.gov.

We have summarized five high impact issues related to the stability studies for drug substances that are documented in the Type II drug master files (DMFs) supporting Abbreviated New Drug Applications (ANDAs). We intend to provide the scientific considerations for the regulatory policies which bear upon such high-impact issues. We have also provided our perspective to avoid such issues, to reduce the DMF review time, and subsequently to accelerate the approvals of the supporting ANDAs.

UI	MeSH Term	Description	Entries
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval