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Center for Drug Evaluation and Research (U.S.)
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1
Manual del Centro para la Evaluacion e Investigacion de Farmacos
Rev. 03/16/01.
by
Center
for
Drug
Evaluation
and
Research
(
U
.S.)
Published: [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], 2001
Description: 90 pages : digital, PDF file.
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2
CDER ... report to the nation
by
Center
for
Drug
Evaluation
and
Research
(
U
.S.)
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1998
Description: volumes : illustrations, color ; 28 cm.
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3
Reviewer guidance conducting a clinical safety review of a new product application and preparing a report on the review
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2005
Description: 1 online resource (79 pages)
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4
Guidance for industry dosage delivery devices for OTC liquid drug products
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2009
Description: 1 online resource (10 pages) : illustrations.
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5
Guidance for industry expiration dating and stability testing of solid oral dosage form drugs containing iron
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1997
Description: 1 online resource (3 pages)
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6
Guidance for industry hypertension indication, drug labeling for cardiovascular outcome claims
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2008
Description: 1 online resource (7 pages)
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7
Guidance for industry investigating out-of-specification test results (OOS) for pharmaceutical production
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2006
Description: 1 online resource (14 pages)
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8
Guidance for industry labeling for combined oral contraceptives
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2004
Description: 1 online resource (27 pages)
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9
Reviewer guidance integration of study results to assess concerns about human reproductive and developmental toxicities
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2001
Description: 1 electronic resource (26 pages) : charts.
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10
Reviewer guidance validation of chromatographic methods
Published: Center for Drug Evaluation and Research, 1994
Description: 1 electronic resource (ii, 30 pages)
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11
Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
Published: Center for Drug Evaluation and Research, Food and Drug Administration, Dept. of Health and Human Services, 1987
Description: 1 electronic resource (44 pages)
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12
Guidance for industry SUPAC-IR/MR : immediate release and modified release solid oral dosage forms : manufacturing equipment addendum
Rev. 1.
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1999
Description: 1 online resource (i, 41 pages)
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13
Guidance for industry SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing a...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1997
Description: 1 electronic resource (ii, 36, 6, 6 pages)
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14
Guidance for industry acute bacterial sinusitis, developing drugs for treatment
Rev. 1.
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2007
Description: 1 online resource (20 pages)
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15
Guidance for industry acute bacterial otitis media, developing drugs for treatment
Rev. 1.
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2008
Description: 1 electronic resource (ii, 22 pages)
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16
Guidance for industry acute or chronic bacterial prostatitis, developing antimicrobial drugs for treatment
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1998
Description: 1 online resource (i, 12 pages)
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17
Guidance for industry antibacterial drug products, use of noninferiority studies to support approval
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2007
Description: 1 online resource (4 pages)
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18
Guidance for industry antiviral product development, conducting and submitting virology studies to the agency
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2006
Description: 1 online resource (14 pages)
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19
Guidance for industry immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in viv...
Published: Center for Drug Evaluation and Research, 1995
Description: 1 electronic resource (26, 1 page)
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20
Guidance for industry noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms : recommended prescribing information...
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2005
Description: 1 online resource (25 pages)
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