FDA is amending 21 CFR 314.440(a)(2)

[admin]

FDA is amending 21 CFR 314.440(a)(2) to update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions. FDA is also amending 21 CFR 312.140(a)(1) to update the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs. The new address for all these submissions is:
Office of Generic Drugs (HFD
–600)
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Pl.
Rockville, MD 20855
This rule is effective August 1, 2010.
You may find additional information at:
http://edocket.access.gpo.gov/2010/pdf/2010-15711.pdf


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