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FDA/CDER-AACR-IASLC Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials - 02/28/2020 - 02/28/2020
… human-drugs/fdacder-aacr-iaslc-workshop-address-criticality-tobacco-use-assessment-oncology-therapeutic-trials … … Background: The continued use of tobacco in individuals who have been diagnosed with cancer … assessment within clinical trials Webcast Information A free-of-charge webcast of this workshop will be provided for …
Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
… Patients with diffuse large B-cell lymphoma Event-free survival (EFS) ˟ Traditional Mechanism agnostic* Cancer: … lymphocyic leukemia; mycosis fungoides Progression-free survivial (PFS) Traditional Mechanism agnostic* Cancer: … Neutralizing antibody Traditional Induction of immunity Tobacco dependence Cigarette smokers Exhaled carbon monoxide …
Nicotine-Containing Products
… promotion of innovative products and treatments targeting tobacco dependence. This report discusses a variety of … issues on behalf of the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on … the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Legacy Foundation. These three …
MedWatch, Your Report Can Make a Difference
… reporting instructions pertaining to adverse events with tobacco products. The consumer-friendly form is also now … about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (that’s …
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
… age, diabetes, hypertension, obesity, and alcohol and tobacco use. The relative risk of congenital malformations … diabetes mellitus, hypertension and body mass index, and free text was used to help identify type of loss (i.e., …
2022 Scientific Computing Days - 09/07/2022
… as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated …
Preventable Adverse Drug Reactions: A Focus on Drug Interactions
… in the plasma and result in an increased amount of free drug, but this is only transient because the usual … CYP1A2 is induced in a clinically relevant manner by tobacco smoking. The clearance of theophylline, imipramine, … 2,3 1 Zevin S , Benowitz NL. Drug interactions with tobacco smoking. An update. Clin Pharmacokinet …