Home » FDA Issues Q&A Document About Residual Solvents Standard
FDA Issues Q&A Document About Residual Solvents Standard
The FDA’s Office of Generic Drugs (OGD) says sponsors of ANDA and ANDA supplements approved between July 1, 2008, and July 1, 2009, may provide a commitment within six months of approval to verify excipient makers’ statements used to comply with U.S. Pharmacopeia standard <467> for controlling residual solvents.
ANDA sponsors with approvals in that time period will have to submit information supporting their verifications in a special report, due immediately to the FDA, rather than waiting to submit the information in annual reports, OGD says in a question-and-answer (Q&A) document.
The FDA told generic-drug makers last May they had to comply with the new standard, which took effect July 1, 2008. The agency issued a draft guidance last August.
Drug GMP Report
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May