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Pharmaceutical and Medical Device Product Liability Litigation
Published in Julie Dickinson, Anne Meyer, Karen J. Huff, Deborah A. Wipf, Elizabeth K. Zorn, Kathy G. Ferrell, Lisa Mancuso, Marjorie Berg Pugatch, Joanne Walker, Karen Wilkinson, Legal Nurse Consulting Principles and Practices, 2019
Vicki W. Garnett, Stacy Newsome
When pharmaceutical companies are required to revise drug labeling, the company must submit revised changes to the FDA, who in turn must approve supplemental label changes based on factors such as side effects, dosage changes, and additional indications for use. The National Institutes of Health (NIH) and U.S. National Library of Medicine (NLM) website DailyMed is another resource that contains over 100,000 drug listings submitted to the FDA and allows consumers to search for drugs based on name, National Drug Code (NDC), drug class, or set ID. DailyMed is the official provider of FDA label information or package inserts and can be accessed at https://dailymed.nlm.nih.gov/dailymed.
Tendinopathy
Published in Kohlstadt Ingrid, Cintron Kenneth, Metabolic Therapies in Orthopedics, Second Edition, 2018
The adverse effects can be confirmed on the product information known as drug labels. Drug labels can be accessed on two U.S. federal websites – the Food and Drug Administration’s (FDA’s) website and the National Institutes of Health’s (NIH’s) resource entitled DailyMed.
The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action
Published in Expert Opinion on Drug Safety, 2018
Zhanhu Zhang, Lili Xu, Zhenyu Zhang, Hongxia Ding, Elizabeth R. Rayburn, Haibo Li
The U.S. National Institutes of Health maintains the DailyMed electronic database, which contains more than 85% of the labels for FDA-approved drugs, and is freely available and searchable at: https://dailymed.nlm.nih.gov/dailymed/. We herein performed a systematic search of the labels of FDA-approved drugs included in the DailyMed database to identify the drugs where the labels recommend that contraception should be used by patients during and/or after treatment. We also summarize the relevant information about these drugs, including the reason why contraception is needed, and (when available) the length of time contraception should be used after the last dose. This brief review should provide a practical reference for medical professionals, health policy makers, researchers interested in reproductive medicine or drug development, and patients who are concerned about their reproductive health.