Did you know that the FDA Rulemaking Process allows for the public to comment before procedural and scientific requirements go into effect? This is the case for both the debut and amendments to regulations and guidance documents. The Agency requests feedback from individuals and companies involved in applying the requirements to their work to ensure that the requirements maximize the benefit to public health while minimizing the burden for implementation experienced by those impacted by the proposed rule or guidance.
The best way to learn about pending proposed rules and guidances is by regularly reading the Federal Register. When a new or amended regulation or guidance is proposed, it will be published in the Federal Register and a docket will be opened for comment at https://www.regulations.gov. The Federal Register notice may limit the areas comments are being solicited for, as in the case of an amendment or when considering time limitations for a public workshop. Sometimes the agency will even hold public workshops on the subject to present their point of view and to gain input from the public prior to issuing a regulation or guidance for comment. Such a meeting would also be announced in the Federal Register.
In the process of finalizing the regulation or guidance document, the Agency will publish a response to all comments received and describe how they were addressed in the final regulation/guidance.
There have been several prominent rules and guidances related to FDA activities opened for comment in the last year. A partial list is provided below, with the intent to show the wide range of items that fall under the rule-making process. There are many dockets that remain open for comment, including the recently released bioequivalence guidance documents.
21 CFR Parts 50 and 56
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Docket closed to comments October 26, 2011)
21 CFR Part 316
Orphan Drug Regulations (Docket closed to comments January 17, 2012)
Draft Guidance for Industry; Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations (Docket open for comment until May 12, 2012)
Draft Guidance for Industry on Implementation of Biologics Price Competition and Innovation Act of 2009 (April 16, 2012)
Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to Reference Protein Product (Docket open for comment until April 16, 2012)
By becoming actively involved in the federal rulemaking process you can help ensure that the umbrella of regulations and guidances you must consider in your work are suitable for “real world” application.
If you have any questions or thoughts on this blog post or others, please contact us.
December 22, 2011
The regulations developed by the FDA for implementing the Orphan Drug Act contain a number of features that are intended to maximize benefits to the orphan disease patient population, but which pose...
January 25, 2017
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...
January 5, 2016
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...