FDA Policy/General

FDA Wants Public Deregulation Input

FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing Prosperity Through Deregulation.”

The statement says the effort is designed to lower the cost of living, remove bureaucratic barriers, and allow healthcare providers to devote more time and resources to patient care.

As part of the initiative, HHS says it will implement these measures:

for every new regulation introduced, at least 10 existing regulations must be eliminated;
the total cost of all new regulations in FY 2025 must be significantly less than zero;
the Executive Order applies not only to formal regulations but also to guidances, documents, memoranda, policy statements, and similar directives; and
HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset to promote greater transparency and accountability.

FDA commissioner Martin Makary said the initiative “is about restoring common sense to healthcare regulation. By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients, not paperwork. We welcome public input to help identify reforms that truly make a difference.”

Stakeholders are asked to submit their ideas for regulatory reform here or here (this portal is said to have tools to assist users in drafting proposals that HHS may formally consider).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome