FDA works toward product naming, packaging guidance
- Ceftolozane/tazobactam medication errors. // Reactions Weekly;Jun2015, Vol. 1554 Issue 1, p1
The article reports that the U.S. Food and Drug Administration (FDA) has issued a warning to healthcare professionals regarding the risk of ceftolozane/tazobactam (Zerbaxa) medication errors.
- Look for a boxed warning against intrathecal use on contrast agents. Rodman, Morton J.; Hurley, Mary Lou // RN;Dec93, Vol. 56 Issue 12, p79
Reports on the request by the Food and Drug Administration (FDA) for contrast agents to carry a boxed warning on carton, vial and package inserts that reads `Not For Intrathecal Use'. `FDC Reports' as source; Severe reactions of patients.
- FDA moves to overhaul package inserts, cut ADEs. Conlan, Michael F. // Drug Topics;1/15/2001, Vol. 145 Issue 2, p47
Reports that the United States Food and Drug Administration (FDA) is proposing a format for prescription drug package inserts that could save billions in hospital costs by reducing adverse drug events. Other benefits of the regulation; Remarks from FDA Commissioner Jane E. Henney; Changes in...
- FDA extends deadline for MedGuide views. // Drug Topics;11/20/95, Vol. 139 Issue 22, p7
Reports on the extension of deadline for comments on the Food and Drug Administration's `Prescription Drug Product Labeling: Medication Guide' proposed rule.
- FDA issues guidance on safety labelling. // Reactions Weekly;8/10/2013, Issue 1465, p3
The article reports on the "Safety Labelling Changes-Implementation of Section 505(o)(4) of the FD&C Act" guidance released by the U.S. Food and Drug Administration (FDA) to clarify the safety labelling changes that may be required under Section 505(o)(4) of the act.
- Worth writing for.... // Arthritis Today;Jul/Aug93, Vol. 7 Issue 4, p12
Presents contact information on how to secure data about labeling requirements and warnings for over-the-counter medicines. Free publication `Safe and Sure Self-Care with Over-the-Counter Medicines' by the Food and Drug Administration.
- Drop radiopharmaceuticals from pediatric rule? Dickinson, James G. // Medical Marketing & Media;Jun98, Vol. 33 Issue 6, p34
Reports that University of California, Los Angeles (UCLA) professor of radiological sciences, Carol S. Marcus, is requesting that the United States Food and Drug Administration, remove all radiopharmaceuticals from its draft list of approved drugs, needing pediatric labelling. Reasons cited for...
- GnRH agonists warning. // MPR - Urologists' Edition;Fall2010/Winter2011, Vol. 7 Issue 1, pA6
The article reports on the notification issued by the Food and Drug Administration (FDA) to the manufacturers of Gonadotropin-Releasing Hormone (GnRH) agonists regarding the additional safety information that should be placed on drug labels to warn perople on the increased risk of diabetes and...
- FDA loking for a few, good words to clarify drug usage. Conlan, Michael F. // Drug Topics;10/24/94, Vol. 138 Issue 20, p73
Reports on the Food and Drug Administration's (FDA) search for words to clarify drug usage for a possible change in labeling rules for over-the-counter (OTC) drugs. Loss of impact of repetitive terms; Use of negative terms for the most important warnings; Approval of word pairs that can be used...