I stumbled across the FDA’s recently published “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012” while surfing the PharmTech website late last week. The guide is published each year in the spring to provide a “heads-up” on which guidance documents the FDA thinks they will be able to complete and publish by the end of the calendar year.
I first learned about the significance of the annual document about 18 months ago when an FDA official explained it in a conference presentation. In response to a question from the audience about when she thought the FDA would publish the Track & Trace (T&T) standard for pharmaceuticals, she recommended that people watch for a notice of it in the “Guidance Agenda…” each year. She said Continue reading InBrief: FDA To Publish Track & Trace Standard By Year End