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# Use New Regulations to Ease Regulatory Burden: MIWG
- URL: https://www.fdaweb.com/use-new-regulations-to-ease-regulatory-burden-miwg/
- Published: 2017-12-13T12:00:00.000Z
- Updated: 2026-09-14T23:07:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140341

The Medical Information Working Group (MIWG) says that while in some cases it is appropriate for FDA to eliminate existing regulations, such as where they lack clarity or are inconsistent with current policy reflected in guidance documents, it also believes that, in some areas, regulatory burdens are alleviated when agencies promulgate new regulations to clarify their expectations and practices. MIWG was [responding](https://www.regulations.gov/document?D=FDA-2017-N-5101-0014&ref=fdaweb.com) to an FDA request for comment and information to help the agency identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing it to achieve its public health mission and fulfill statutory obligations.

In the absence of regulations, MIWG says, regulated entities cannot consistently conform their conduct to regulatory expectations. Also, it says, without the kinds of clear, binding rules that can only be devised through notice-and-comment rulemaking, industry is forced to allocate significant resources to identifying applicable norms through regulatory intelligence gathering, legal and regulatory analysis, and other resource-intensive compliance activities. “These measures are less necessary if the applicable rules are readily discernible in the governing law itself, that is, in codified regulations adopted through notice-and-comment procedures,” the letter says.

Addressing manufacturer communications, MIWG says the primary deficiency in the FDA regulatory scheme is not the proliferation of regulations, but that the existing regulations lack sufficient consistency and clarity.

Specific comments were provided by the [Association for Accessible Medicines](https://www.regulations.gov/document?D=FDA-2017-N-5101-0013&ref=fdaweb.com) and [International Pharmaceutical Excipients Council of the Americas](https://www.regulations.gov/document?D=FDA-2017-N-5101-0008&ref=fdaweb.com).