Drug LabelingSafetyUnited States Food and Drug AdministrationUnited StatesFocuses on summaries of safety-related drug labeling changes which can be found on the MedWatch homepage on the Internet. Address of the homepage; Inclusions of the summaries.doi:10.3109/15563659809028067...
The MedWatch Program: Safety-Related Drug Labeling Changes Approved by FDAEvaluation the etiopathogenesis of this set autoimmune muscle diseases.doi:10.3109/15563659809028037White, Gale G.Love, LoriTaylor & FrancisClinical Toxicology
Safety-related drug labeling changes approved by FDA. Focuses on summaries of safety-related drug labeling changes which can be found on the MedWatch homepage on the Internet. Address of the homepage; Inclusio... White,Gale,G. - 《Journal of Toxicology Clinical Toxicology》 被引量: 1发表: 19...
Changes to drug safety labeling by the Food and Drug Administration (FDA) provide patients and providers with the most up-to-date information about a product's risk. Ad However, too little is known about the impact of these changes and whether they haveunintended consequences, such as dissuad...
(Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products), which, if finalized, would have allowed generic drug makers to independently – meaning, without prior FDA review and approval – update and promptly distribute new safety information in drug labels. Th...
US Food and Drug Administration, Safety-related drug labeling changes. Available at: http://www.fda.gov/medwatch/safety.htm. Accessed May 6, 2004 12. US Food and Drug Administration, Patient labeling and risk communication. Available at: http://www.fda.gov/cder/offices/ODS/labeling.htm. Ac...
One of these NISS was related to naloxone hydrochloride product administration. There were attempts to administer a syringe that had no needle. In response, FDA required changes to carton labeling to include a warning that said, “Needle not included.” Other safety efforts by CDER include ...
New Drugs Approved by the FDA New Dosage Forms and Indications Agents Pending FDA Approval Labeling Changes Related to SafetySeveral tables are presented which show various U.S. Food and Drug Administration (FDA)-related drug information including one on the additional drugs approved by the FDA, ...
safetyKoreaUS FDAThe objective of this study was to analyze information on pediatric use in Korean drug product labels, and compare them to those US FDA labeling information. Prescription information on pediatric use contained in the commonly used drugs' product labels approved by Korean government ...
Label Changes We queried FDA’s New Pediatric Labeling Information Database to identify whether studies were conducted under BPCA alone or under both BPCA and PREA.19,20 We then extracted labeling changes for the 54 drugs within our cohort, including safety and efficacy outcomes. We also determi...