FDA Requests Input on Clinical Outcome Assessments Compendium

January 14, 2016

On April 1, 2015, FDA held a public workshop entitled, “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” During the meeting, the Agency provided “updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs).”

What is the COA Compendium?

As a part of its efforts to foster patient-focused drug development the FDA developed the pilot COA Compendium, which is “a table that:

  • Describes how certain clinical outcome assessments have been used in clinical trials to measure the patient’s experience (such as disease-related symptoms) and to support labeling claims.
  • Identifies clinical outcome assessments that have been qualified for potential use in multiple drug development programs under the COA type of the Drug Development Tool (DDT) Qualification Program of the Center for Drug Evaluation and Research (CDER).
  • Recognizes ongoing qualification projects to encourage community collaboration in the development of clinical outcome assessments for unmet measurement needs.”

The FDA developed the COA Compendium with the intention of facilitating communication and providing “clarity and transparency to drug developers and the research community by collating and summarizing COA information for many different diseases and conditions into a single resource. It can be used as a starting point when considering how certain clinical outcome assessments might be utilized in clinical trials and will likely be most informative in early drug development.”

Establishment of a Docket

On January 13, FDA announced the establishment of a docket, which will be used “to receive suggestions, recommendations, and comments from interested parties,” regarding the first version of its pilot COA Compendium.

The FDA made this announcement in the Federal Register, and stated that the comments received during the COA Compendium’s pilot phase “will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA's web site.”

Comments are being accepted until March 14, 2016, and can be made via paper or electronic submission (here).

For more information on the FDA's COA Compendium, view our blog post.

Agency Alerts General Regulatory

August 20, 2015

FDA Released Draft Guidance on Common Issues in Rare Disease Drug Development

After the FDA passed the Orphan Drug Act in 1983, the number of orphan drugs (drugs indicated for the treatment of rare diseases that affect 200,000 people or less in the United States) submitted to...

Read the Full Article
Agency Alerts General Regulatory

January 25, 2017

Medical Product Communication, Part Two: Medical Product Communications That are Consistent with the FDA-Required Labeling – Questions and Answers

After various industry professionals and stakeholders expressed an interest in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft...

Read the Full Article
Agency Alerts General Regulatory

April 18, 2016

FDA Reopens Comment Period for Proposed Rule Regarding Regulation of Fixed-Combination Drugs

On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs. In its announcement, FDA proposed that its requirements for prescription fixed-combination...

Read the Full Article