You Do Have a Voice – The FDA Rulemaking Process

March 26, 2012

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 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 Guidances
Draft Guidance for Industry; Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations (Docket open for comment until May 12,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Draft Guidance for Industry on Implementation of Biologics Price Competition and Innovation Act of 2009 (April 16, 2012)

Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to Reference Protein Product (Docket open for comment until April 16, 2012)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.

March 26, 2012

Biomanufacturing World Summit

The Biomanufacturing World Summit brings together the “who’s who” of pharmaceutical executives and cutting-edge technology providers for North America’s premier biologics event. Make plans to attend,...

Read More
Process Validation Life Science Consulting

March 26, 2012

Mergers, Acquisitions and Consolidations: Whose Validation Standards Do I Use?

If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...

Read More
Qualification & Validation Life Science Consulting

March 26, 2012

Three Solutions to Typical Autoclave Temperature Mapping Conundrums

Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...

Read More