January 6, 2023

Dear Colleague,

As you and other public health advocates work on the front lines, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA’s work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.

Protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.

News Release

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

Today, the FDA approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.

Consumer Updates

Should You Give Kids Medicine for Coughs and Colds?

Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you might want to give your child medicine to treat a cold. But most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.

In addition, some cough and cold medicines can have serious side effects, such as slowed breathing, which can be life-threatening, especially in infants and young children. For those reasons, it’s important to know when your child needs medication, which treatments are recommended, and when to do without medicine.

COVID-19 Test Basics

There are different types of COVID-19 tests – diagnostic tests and antibody tests.

Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two common types of COVID-19 diagnostic tests:

• Molecular tests, such as polymerase chain reaction (PCR) and other nucleic acid amplification tests (NAATs) tests, which detect genetic material called RNA from the virus
• Antigen tests, often referred to as rapid tests or, for some, at-home or self tests, which detect proteins called antigens from the virus

Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement

Millions of people have thyroid glands that don’t make enough thyroid hormone to meet their body’s needs. Hypothyroidism, also called underactive thyroid, is the most common reason some people need thyroid hormone replacement.

Hypothyroidism is treated by replacing the hormones that your own thyroid can no longer make. Thyroid hormone medicines mimic these hormones.

Thyroid hormone has been used as medicine for decades. The first versions of thyroid hormone medicines were made from the thyroid glands of pigs or cows and are not approved by the FDA. Today, there are modern, synthetic (laboratory-made) medications approved by the FDA. Most patients with hypothyroidism use these modern thyroid replacement drugs.

Webinars and Virtual Workshops

Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19

January 11, 2023; 12:05 PM - 1:00 PM ET

The FDA will continue hosting the virtual town hall series on test development and validation during public health emergencies to provide information and answer questions about test development.

Registration is not required.

FDA Grand Rounds: The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars

January 12, 2023; 12:00 PM - 1:00 PM ET

This presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process FDA utilized for review of the highly influential scientific assessments for these proposed rules.

FDA Oncology Center of Excellence Project Community Initiative: 2023 National Black Family Cancer Awareness Week - Community Forum

January 12, 2023; 3:00 PM - 4:00 PM ET

The purpose is to increase cancer awareness in one of the most vulnerable segments of the US population. While formal national organization involvement is welcome, National Black Family Cancer Awareness Week aims to marshal community-based stakeholders to increase cancer awareness and to build knowledge surrounding cancer clinical trial participation as well as minority population specimen donations to national genetic databases for cancer research.

FDA’s Labeling Resources for Human Prescription Drugs

January 26, 2023; 1:00 PM - 2:00 PM ET

This webinar will discuss FDAs labeling resources for human prescription drugs for pharmaceutical industry members. Additionally, the webinar will discuss a new prescription drug labeling resource for healthcare professionals and patients: Frequently Asked Questions about Labeling for Prescription Medicines.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder 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, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.