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FDA Issues Regulatory Update

Aug 10, 2026

August 10, 2026

Dear Colleague,

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics.  Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients, and consumers, MedWatch, receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are here:

Updates

Spotlight

FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms

The U.S. FDA approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults.  Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first to work by directly targeting the loss of orexin signaling that causes the disease.

FDA Voices

Investing in FDA’s Inspectional Enterprise

By: Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations and Lowell Zeta, JD, Acting Chief of Staff and Deputy Commissioner for Strategic Initiatives

At the U.S. FDA, transparency with our stakeholders is essential to our mission.  Patients, healthcare providers, and industry rely on a regulatory system that is rigorous, but also predictable, understandable, and accountable.  As part of the FDA’s broader transparency efforts, we are taking steps to modernize how we communicate, how we make decisions, and how we carry out regulatory responsibilities.  A critical component of that effort is the transformation of our inspectional enterprise, including how we plan, coordinate, and execute inspections across the agency.

America Must Address Early Clinical Development

By: Karim Mikhail, B. Pharm, MSc, Acting Director of the Center for Biologics Evaluation and Research

America is losing ground on clinical trials.  Phase 1 trials that may take up to two years to complete here in the United States are completed in nine months in China, threatening America’s leadership in scientific innovation.  To combat this, President Trump and Secretary Kennedy have directed the U. S. FDA to use every tool at its disposal to reverse this trend.  The consequences are broad.  Patients lose access to investigational therapies and may have to travel abroad to enroll.  The FDA’s ability to shape science and oversee safety diminishes when trials move overseas.  For investors, slower and less predictable U.S. regulatory timelines push early-stage capital, along with jobs and intellectual property, to other countries.

Guidance Documents

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About Us

The Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs.  We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations.  For more information, please contact us at: PublicEngagement@fda.hhs.gov.  For patient specific inquiries, please contact us at: Patients Ask FDA.