FDA to Change Long Standing Practice of Not Posting Individuals’ Comments Publicly

September 22, 2015

In the past, FDA has made a point that comments posted by individuals (in an individual capacity and not on behalf of an organization, corporation, or other entity) are not posted publicly. This is a practice that has applied only to comments from individual consumers (comments from organizations, etc. are posted publically and displayed on regulations.gov).

Starting on October 15, 2015, FDA is set to change this policy and will begin posting all comments publicly. This practice, that was implemented to ensure “that the submitted comment does not include confidential information that the commenter or third party may not wish to be posted,” is being changed by the Agency in an attempt to increase transparency and promote the sharing of information.

In addition to the comments, FDA will be posting “any attachments submitted electronically, along with the State/Province and country (if provided), the name of the commenter’s representative (if any), and the category selected to identify the commenter (e.g., individual, consumer, academic, industry).” As such, the Agency warns against including confidential information that the commenter does not want posted publicly; examples of such information include: private medical information, social security number(s), or confidential business information (i.e. a manufacturing process).

For more information on the change, view the full notice here.




Agency Alerts Regulatory Sciences

September 22, 2015

FDA Approves New Opioid Despite Controversy

On Friday, November 2nd, FDA announced its approval of Dsuvia™, a highly potent synthetic opioid manufactured by AcelRx Pharmaceuticals, Inc.  The drug is a sublingual (under the tongue) formulation...

Read More
Agency Alerts General Regulatory

September 22, 2015

FDA Seeks Nominations for Members to Serve on the Tobacco Products Scientific Advisory Committee

On Monday, August 15th, FDA issued a notice requesting nominations for a nonvoting member to serve on the Tobacco Products Scientific Advisory Committee to represent the interests of tobacco...

Read More
Agency Alerts General Regulatory

September 22, 2015

Clinical Trials Day 2016: Increasing Clinical Trial Awareness & Participation

Every year on or near May 20th, Clinical Trials Day is celebrated. The internationally observed celebration recognizes the first randomized clinical trial, conducted in 1747 by James Link. In a...

Read More