NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (NDAC)
IN JOINT SESSION WITH THE
ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS (ACRHD) MEETING
* * *
TUESDAY,
Errata Sheet
Page 125, lines 7 and 8:
“….the product, that’s” should be
“product based on”
Page 125, line 22:
“..may be reached by” should be “….may
be enriched by”
Page 126, line 10:
“…and it can time…” should … “and can
correctly time..”
Page 126, line 13:
“The second objective…” should be “The
secondary objectives…”
Page 127, line 12:
“… pregnancy studies…” should be “…
pregnancy status…”
Page 127, line 20:
“the remaining six from….” should be
“the remaining 6% from ….”
Page 129, line 2:
Delete “had a problem,”
Page 129, line 20:
“The sponsor realigned second…” should
be “The sponsor reanalyzed the second….”
Page 130, line 1:
“If needing the first…” should be “If
leaving the first….”
Page 130, line 13:
“At least one such” should be “At least
one sex”
Page 130, line 15:
“User” should be “Use of”
Page 131, line 6:
“…. 40 subjects,” should be “…..14
subjects,”
Page 131, line 17:
“no
new statistic loss (phonetic).”should be “no new
safety signal.”
Page
132, line 2:
“The
formal period” should be “The follow-up period”
Page 132, line 13:
“non-tour
(phonetic)” should be “long-term”
Page
132, line 19:
“enclosed”
should be “included”
Page
132, line 22:
delete
“in” (before “outside the
Page 133, line 10:
“I
have” should be “had”
Page
133, line 12:
“of”
should be “or”
Page
133, line 12-13:
“.Many”
should be “, meaning”
Page
134, line 2:
“The
formal period” should be “The follow-up period”
Page
134, line 5:
“The
08 studies, such as with” should be “The 8
studies suggest that”
Page
134, line 6:
Delete
“,” after “provision”
Page
134, line 8:
Delete
“such as with”
Page
134, line 9:
Delete
“,” after “provision”
Page
134, line 10:
“mass”
should be “more”
Page
143, line 9:
“he”
should be “you”
Page
143, line 11-15
“For
this study particularly,
actually
such as were reimbursed in the end of --
after
second contact from my understanding, but they
were
told they would get reimbursed after enrollment
for
this one.” should be “For this study, subjects were reimbursed in
the end of the second contact for my understanding, but they were told they
would get reimbursed at the enrollment.”
Page
143, line 16:
“this
confining factor here,” should be “this is a
confounding factor here,”
Page
143, line 17:
“pay,
if” should be “pay, or if”
Page
143, line 19:
“So
this is very tight (phonetic),” should be “This is a
big challenge to us,”