CDER guidance agenda
This article was originally published in The Rose Sheet
Executive Summary
"Minimum Data Elements to be Included in a Serious Adverse Event Report for Monograph OTC Products" is one of 40 guidances the Center for Drug Evaluation and Research plans to develop during 2007. According to the March 19 release, the agenda items are "under development as of the date of this posting." Sunscreens, antiperspirants and treatments for dandruff and acne are among products regulated under FDA over-the-counter monographs. The "Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006" (S 3546), signed into law in late 2006 and effective in December, establishes mandatory reporting of serious adverse events associated with such products (1"The Rose Sheet" Jan. 29, 2007, p. 7). The list of guidances includes "Labeling of Over-the-Counter Skin Protectant Drug Products"...
You may also be interested in...
Expert Gives Lowdown On Adverse Event Reporting Bill For Monograph OTCs
The compliance of companies newly subject to adverse event reporting and record-keeping requirements will likely be evaluated by FDA on a "performance-oriented basis," said Rick Kingston, PharmD, president and senior clinical toxicologist at SafetyCall International, an adverse event call center
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.