-
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...
-
during Phase III
clinical trials, i.e. they were only made
apparent from
postmarketing surveillance data
collected from the
wider community over
longer periods...
- For
cardiovascular death, the FDA
based its
decision on a
postmarketing study it
required when it
approved empagliflozin in 2014, as an adjunct...
-
Public health surveillance (also
epidemiological surveillance,
clinical surveillance or
syndromic surveillance) is,
according to the
World Health Organization...
- of
drugs that have not been
fully approved by the FDA 21 CFR 314.80:
Postmarketing Reporting of
Adverse Drug
Experiences "MedWatch: The FDA
Safety Information...
- mimetics. Of
particular concern is
exenatide that was
linked to 36
postmarketing reports of
acute pancreatitis soon
after its introduction.
Further inquiry...
- PDE5
inhibitor use. Rare but
serious adverse effects found through postmarketing surveillance include prolonged erections,
severe low
blood pressure...
- 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...
