Search Results - "Kennedy, Dianne L."

Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective by Patrick, Donald L., PhDMSPH, Burke, Laurie B., RPhMPH, Powers, John H., MDFACPFIDSA, Scott, Jane A., PhD, Rock, Edwin P., MDPhD, Dawisha, Sahar, MDFACPFACR, O'Neill, Robert, PhD, Kennedy, Dianne L., RPhMPH

“…Abstract This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report…”
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Patient-Reported Outcomes Supporting Anticancer Product Approvals by Rock, Edwin P, Kennedy, Dianne L, Furness, Melissa H, Pierce, William F, Pazdur, Richard, Burke, Laurie B

“…In 2006, the US Food and Drug Administration (FDA) published draft guidance to provide recommendations for development, validation, implementation, and…”
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Antibiotic use in pregnancy and lactation : What is and is not known about teratogenic and toxic risks by NAHUM, Gerard G, UHL, Kathleen, KENNEDY, Dianne L

“…Over ten million women are either pregnant or lactating in the United States at any time. The risks of medication use for these women are unique. In addition…”
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Evolution of Clinical Trials for Irritable Bowel Syndrome: Issues in End Points and Study Design by Trentacosti, Ann Marie, He, Ruyi, Burke, Laurie B, Griebel, Donna, Kennedy, Dianne L

“…Irritable bowel syndrome (IBS) involves a broad range of physiological and psychological alterations that may affect brain-gut dysregulation, gut function,…”
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Risk management strategies in the Physicians' Desk reference product labels for pregnancy category X Drugs by UHL, Kathleen, KENNEDY, Dianne L, KWEDER, Sandra L

“…Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many…”
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Pregnancy exposure registries by KENNEDY, Dianne L, UHL, Kathleen, KWEDER, Sandra L

“…Scientifically valid data on the safety of drug use during pregnancy are a significant public health need. Data are rarely available on the fetal effects of in…”
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Challenges to Use of Health-Related Quality of Life for Food and Drug Administration Approval of Anticancer Products by Rock, Edwin P., Scott, Jane A., Kennedy, Dianne L., Sridhara, Rajeshwari, Pazdur, Richard, Burke, Laurie B.

“…The U.S. Food and Drug Administration (FDA) approves labeling claims of drug efficacy based on substantial evidence of clinical benefit demonstrated in…”
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Information on medication use in pregnancy by Uhl, Kathleen, Kennedy, Dianne L, Kweder, Sandra L

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Disease modifying antirheumatic drugs and pregnancy by Uhl, Kathleen, Kennedy, Dianne L, Gilliland, William R

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Complex clinical, legal, and ethical issues of pregnant and postpartum women as subjects in clinical trials by Uhl, Kathleen, Miller, Margaret Ann, Kennedy, Dianne L

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Accurate information on drug effects on pregnancy is crucial by Uhl, Kathleen, Kennedy, Dianne L, Kweder, Sandra L

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Prescribed Use of Cholesterol-Lowering Drugs in the United States, 1978 Through 1988 by Wysowski, Diane K, Kennedy, Dianne L, Gross, Thomas P

“…Data from two pharmaceutical marketing research databases, the National Prescription Audit and the National Disease and Therapeutic Index, were used to study…”
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Noncontraceptive estrogens and progestins: use patterns over time by Kennedy, D L, Baum, C, Forbes, M B

“…The use of noncontraceptive estrogens and progestins, particularly in menopausal women, has been a subject of considerable controversy during the past decade…”
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Oral contraceptives in the United States: trends in content and potency by Piper, J M, Kennedy, D L

“…Data from the National Prescription Audit, a nationwide pharmaceutical marketing research data base, were reviewed to study changes in the type of oral…”
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Oral contraceptive oestrogen and progestin potencies and the incidence of deep venous thromboembolism by Gerstman, B B, Piper, J M, Freiman, J P, Tomita, D K, Kennedy, D L, Ferguson, W J, Bennett, R C

“…To assess possible differences in the incidence of venous thrombosis and pulmonary embolism associated with oral contraceptives of varying hormonal potencies,…”
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Monitoring of Adverse Drug Events in Hospitals by Kennedy, Dianne L, Johnson, Joyce M, Nightingale, Stuart L

“…The article appearing in this issue of JAMA by Classen et al,1 "Computerized Surveillance of Adverse Drug Events in Hospital Patients," emphasizes the…”
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Medications and the safety of the older driver: is there a basis for concern? by Ray, W A, Gurwitz, J, Decker, M D, Kennedy, D L

“…Medications with central nervous system (CNS) effects, including benzodiazepines, cyclic antidepressants, antihistamines, narcotic analgesics, and…”
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Drug Use in the United States in 1981 by Baum, Carlene, Kennedy, Dianne L, Forbes, Mary B, Jones, Judith K

“…This study provides national estimates of outpatient prescription drug use based on pharmaceutical marketing data. An analysis of total outpatient exposure…”
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MedWatch: FDA's new medical products reporting program by Kessler, D A, Kennedy, D L

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Drug Use and Expenditures in 1982 by Baum, Carlene, Kennedy, Dianne L, Forbes, Mary B, Jones, Judith K

“…This article provides national estimates of drug use and drug expenditures in 1982. Total outpatient drug exposure increased 5% from 1981 to 1982 and 28% from…”
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