Drugs Approved for Cancer Indications - A current
listing of new cancer drugs.
Drug Approvals List. Chronological listing of all drugs
(NDAs, ANDAs. NDA labeling supplements, efficacy
supplements) approved since September 1996.
(OTC) Home Page. Contains info on labeling requirements
for OTC drugs.
Changes Related to Drug Safety. Part of MedWatch.
Contains summaries of safety related changes to labeling.
Drug Info Page. Contains links to labeling for many
brand name products.
OTC Human Drug Products - Updating Labeling in ANDAs.
Draft OTC guidance for OTC products.
FDA Reviews Drug Names. An "FDA Safety Page"
from Drug Topics describing the review of a
Pharmaceuticals for Children Act. Section 11 allows for
approval of an ANDA when pediatric indication is protected
by patent or exclusivity
for Submission of Labeling to Human Prescription Drugs and
Biologics in Electronic Format. A proposed rule to amend
FDA regulations governing the format in which certain
labeling is required to be submitted for review with NDAs,
ANDAs, supplements, and annual reports.
Differentiation Project. OGD requested
manufacturers of sixteen look-alike name pairs to
voluntarily revise the appearance of their established names
in order to minimize medication errors resulting from