-
terms are defined:
Postmarketing requirements are
studies and
clinical trials that
sponsors are
required to
conduct and
postmarketing commitments are studies...
- Duloxetine, sold
under the
brand name
Cymbalta among others, is a
medication used to
treat major depressive disorder,
generalized anxiety disorder, obsessive-compulsive...
- vaccine, its manufacturers, and
distribution partners; and 2)
conducting postmarketing surveillance,
including records for
adverse events after the vaccination...
- For
cardiovascular death, the FDA
based its
decision on a
postmarketing study it
required when it
approved empagliflozin in 2014 as an adjunct...
-
during Phase III
clinical trials, i.e. they were only made
apparent from
postmarketing surveillance data
collected from the
wider community over
longer periods...
- Sodium–Glucose Cotransporter-2 Inhibitors: A
Review of
Spontaneous Postmarketing Cases". Ann
Intern Med. 170 (11): 764–769. doi:10.7326/M19-0085. PMID 31060053...
-
Prevention (CDC) and the Food and Drug
Administration (FDA).
VAERS is a
postmarketing surveillance program,
collecting information about adverse events (possible...
-
Public health surveillance (also
epidemiological surveillance,
clinical surveillance or
syndromic surveillance) is,
according to the
World Health Organization...
- "Serotonin
toxicity ****ociated with the use of linezolid: a
review of
postmarketing data".
Clinical Infectious Diseases. 42 (11): 1578–83. doi:10.1086/503839...
-
Puerto Rico facility,
where the drug is to be manufactured;
Several postmarketing surveillance commitments, and follow-up
studies on low-dose use, relapse...
