FDA Simplifies the Search for Guidance Documents

August 12, 2015

FDA Guidance Documents - Dynamic Search Tool

As many of us know, searching for an FDA guidance document from the past can be a rather daunting task. That  is until recently…

Guidances are one of the most requested and searched for items on the Agency’s website, which has led them to design and launch a dynamic search tool that is located on one website, allowing users to visit just one page to search for, and find the guidance document(s) they need.

Launched as part of their Transparency Initiative, this search page has increased the Agency’s website traffic immensely. Announced in December 2014, FDA is still collecting feedback and suggestions for improvement. Visit their website and use this awesome new tool here.

Are you in the process of developing a product that may be subject to the guidelines provided in the Agency’s recent draft guidance? We can help you achieve successful interactions with the Agency and get your product approved by the FDA. Contact us today to learn more about our services and how we can be of assistance to you.


November 19, 2015

FDA Holds Public Workshops to Discuss Regulatory Strategies for Next Generation Sequencing Diagnostics, Part 1

As we discussed in a previous FDA News article, the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s ultimate goal...

October 8, 2015

Senator: FDA’s Backlog of ANDAs is Causing “Harm” to Consumers

On September 28, 2015, Sen. David Vitter (R-LA) sent a letter to FDA’s Acting Commissioner, Stephen Ostroff, MD, in which he stated various concerns regarding an extensive backlog of Abbreviated New...

September 2, 2015

Kim Kardashian Cleans Up Social Media Mess for Duchesnay

As we noted a few weeks ago, Duchesnay, the company that manufactures prescription morning sickness medication Diclegis, received a warning letter from FDA after Kim Kardashian posted a "selfie" on...