United States Food and Drug Administration Drug Approval Summary [PDF]
Clinical Cancer Research, 2004 Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Richard T. Lostritto +11 more
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Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine [PDF]
Journal of the American Veterinary Medical Association, 2004 Victoria Hampshire +8 more
semanticscholar +5 more sources
The United States Food and Drug Administration and Prescription Drug Promotion. [PDF]
J Innov Card Rhythm Manag, 2019 The impact of prescription drug promotion on health-care professionals (HCPs) is significant. Pharmaceutical industry spending on promotion to HCPs greatly outpaces spending on direct-to-consumer promotion. According to Syneos Health™ PromotionalAnswers, in 2017, the pharmaceutical industry spent more than $24 billion on drug promotion, with more than $
Kalola AS, Dean R.
europepmc +5 more sources
Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue. [PDF]
BMC Pregnancy Childbirth, 2019 BackgroundMaternal heart rate artefact is a signal processing error whereby the fetal heart rate is masked by the maternal pulse, potentially leading to danger by failure to recognize an abnormal fetal heart rate or a pre-existing fetal death.
Kiely DJ, Oppenheimer LW, Dornan JC.
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WHEELCHAIR SAFETY???ADVERSE REPORTS TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION
American Journal of Physical Medicine & Rehabilitation, 1994 Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by the FDA between 1975 and 1993.
Stacey A. Ackroyd-Stolarz, R. Lee Kirby
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Rheumatic and Musculoskeletal Adverse Events with Immune Checkpoint Inhibitors: Data from the United States Food and Drug Administration Adverse Event Reporting System [PDF]
Journal of Immunotherapy and Precision Oncology, 2019 Background: Despite their efficacy, immune checkpoint inhibitors (ICIs) can cause significant immune-related adverse events (irAEs). Rheumatic and musculoskeletal irAEs can be serious and adversely affect the quality of life.
Xerxes Pundole +2 more
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United States Food and Drug Administration and the Pharmaceutical Industry [PDF]
BMJ, 1961 Jane Garland
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Specificity of HercepTest in Determining HER-2/neu Status of Breast Cancers Using the United States Food and Drug Administration–Approved Scoring System [PDF]
Journal of Clinical Oncology, 1999 Timothy W. Jacobs +4 more
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United States Food and Drug Administration approved oral kinase inhibitors for the treatment of malignancies [PDF]
Current Problems in Cancer, 2013 The United States Food and Drug Administration (FDA) has approved 19 oral kinase inhibitors (KIs) for the treatment of malignancies in hematology and oncology as of May 2013, see Table 1. We review the general principles and guidelines for using KIs for cancer treatment. This article is not designed for cross-trial comparison or to make recommendations
Woondong Jeong +2 more
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An introspection of quality of novel drug approvals by United States Food and Drug Administration
International Journal of Basic & Clinical Pharmacology, 2018 Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance ...
Rekha Mehani, Ajay Kumar Shukla
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