Sometimes a year will go by and the regulatory process will seem to move in geologic time (versus real time) and nothing new has happened, that was NOT the case in 2017 which has shaped up to be a very a busy year for the FDA and drug developers. This article will explore all the major changes this year including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas not covered herein but might be of interest to you; the impact of these changes is provided for some of the information. First stop, a new CEO for the FDA, or in FDA speak, a new commissioner.
The head of the FDA is like a Captain of a ship, the CEO; this person sets the tone for interpretation of regulations, application of regulations and what regulations will be focused on. Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017 and has been busy every since doing what he can to streamline drug development (from both the Sponsor and FDA perspective), speed up breakthrough therapy reviews, issue more guidance documents and crack down on the opioid addiction epidemic. Based on his brief output for 2017, 2018 will be another whirlwind year as well.
The beginning of 2017 was a busy time for the FDA, there was a flood of guidance documents published in the Federal Register as either draft or final guidance document as it seemed like the FDA wanted to get through as many guidance documents as possible prior to the regime change since a new president usually means a change in the head of the FDA.
Following is a list of all guidance documents published in 2017 so far, their status followed with all manufacturing guidance documents highlighted. Want to know where you can check for new guidance documents? FDA posts them here.
Search for the guidance document you want here.