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An introspection of quality of novel drug approvals by United States Food and Drug Administration [PDF]

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
Mehani, Rekha, Shukla, Ajay K.
core   +5 more sources

United States Food and Drug Administration seeks global regulatory regime. [PDF]

CMAJ, 2011
The United States Food and Drug Administration (FDA) is proposing to develop and lead a more coordinated global approach to the inspection and monitoring of foods, drugs and medical devices. Globalization is forcing the development of a more coordinated international approach to regulation of ...
Walkinshaw E.
europepmc   +5 more sources

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
PURPOSE To evaluate the specificity of the HercepTest for Immunoenzymatic Staining (Dako Corp, Carpinteria, CA) for determining HER-2/neu protein expression in breast cancer. MATERIALS AND METHODS Forty-eight invasive breast cancers previously found to
Timothy W. Jacobs, Allen M. Gown, Hadi Yaziji, Melissa J. Barnes, Stuart J. Schnitt   +4 more
openalex   +2 more sources

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration. [PDF]

J Pediatr, 2019
Liu XI, Schuette P, Burckart GJ, Green DJ, La J, Burnham JM, Rakhmanina N, Robb A, Huang SM, van den Anker JN.   +9 more
europepmc   +3 more sources

Concomitant Risk Factors in Reports of Torsades de Pointes Associated with Macrolide Use: Review of the United States Food and Drug Administration Adverse Event Reporting System [PDF]

Clinical Infectious Diseases, 2002
In this case series, we examined concomitant risk factors mentioned in reports of torsades de pointes, a rare ventricular arrhythmia, that occurred in association with administration of macrolide antimicrobials (e.g., azithromycin, clarithromycin ...
Douglas Shaffer, Sarah J. Singer, Joyce A. Korvick, Peter K. Honig   +3 more
openalex   +2 more sources

United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy [PDF]

Clinical Cancer Research, 2006
Purpose: On March 25, 2005, bortezomib (Velcade for Injection; Millennium Pharmaceuticals, Inc., Cambridge, MA, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) received regular approval from the U.S. Food and Drug Administration (U.S.
Robert C. Kane, Ann T. Farrell, Rajeshwari Sridhara, Richard Pazdur   +3 more
openalex   +2 more sources

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
Margarita A Brown, Roderick Hudson, Priscilla O Batten, Tina M Burgess, Frederick M Doddy, Victoria A Hampshire, Teresa L Koogler, Dorothy R McAdams, Lynn O Post   +8 more
semanticscholar   +5 more sources

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, David L. Morse, Grant A. Williams, Sophia Abraham, Rajeshwari Sridhara, W. David McGuinn, Chenyi Liang, Atiqur Rahman, Amy Baird, Martin H. Cohen, Gang Chen, Richard Pazdur   +11 more
openaire   +3 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

Intraspinal steroids: history, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports [PDF]

Journal of Neurology Neurosurgery & Psychiatry, 2001
This review, covering a timespan of almost a century, attempts to answer five pressing questions: (1) Are intraspinal steroid therapies effective for back pain or radicular syndromes?
Dewey A. Nelson
openalex   +2 more sources