FDA Policy/General

Workshop on Drugs/Biologics Used During Lactation

Federal Register Notice: FDA is planning a public workshop 4/27-28 entitled “Evaluation of the Safety of Drugs and Biological Products Used During Lactation.” Attendees will discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. It will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation. The workshop will be held 4/27, from 8 a.m. to 5 p.m.; and 4/28, from 8 a.m. to 1 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD. To view this notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome