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FDA White Oak Campus

10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
(240) 402-6887

September 2015

MDUFA Reauthorization: Patient and Consumer Stakeholder Meeting

September 16, 2015 @ 9:00 am - 11:00 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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The NORD policy team will attend this meeting to represent the rare disease community.

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Alpha-1 Patient Focused Drug Development Meeting

September 29, 2015 @ 9:00 am - 3:30 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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The purpose of this Patient-Focused Drug Development meeting is to obtain input on the symptoms and other impacts that matte most to patients with AATD. FDA also intends to seek patients' perspectives on current approaches to treating this disorder. FDA expects that this information will come directly from patients, caregivers, and patient advocates. The questions that will be asked of patients and patient caregivers at the meeting are as follows. The meeting will be divided into two main topics: 1.…

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March 2016

How to Navigate CDER Workshop for Advocacy Groups

March 31, 2016 @ 8:30 am - 5:00 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled “Navigating CDER: What You Should Know for Effective Engagement.”  The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. There will be an opportunity for questions and answers following each presentation. REGISTRATION There is no registration fee to attend the public workshop. Early registration is recommended because…

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May 2017

FDA PUBLIC WORKSHOP: ROADMAP FOR ENGAGING WITH FDA’S CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

May 12, 2017 @ 9:00 am - 3:00 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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Achieve more through your advocacy group with FDA's help.  Attending this workshop will enhance your understanding of how safe and effective drug therapies are approved, so you can advocate for your patients most effectively. This workshop can help you: Get familiar with the drug approval process and tips to ensure your voice is heard. Discover how FDA emphasizes patient needs and goals while making decisions to advance and protect the public's health. Debunk myths about what the FDA can and…

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July 2018

Public Meeting on Patient-Focused Drug Development for Chronic Pain

July 9, 2018 @ 10:00 am - 4:00 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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On July 9, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Chronic Pain. FDA is interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies. The event will be broadcasted…

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November 2018

Leveraging Real-World Treatment Experience from Expanded Access Protocols

November 19, 2018 @ 10:00 am - 4:30 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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Building on the Reagan-Udall Foundation for the FDA’s work with FDA and other stakeholders to develop the Expanded Access Navigator, the Reagan-Udall Foundation is convening stakeholders from government, industry, academia and patient groups to discuss process issues that include: Increase understanding of the expanded access program Identify and discuss strengths, challenges and opportunities Discuss what could be the optimum balance between providing access for treatment and obtaining data in support of regulatory applications How could the data be leveraged? How could…

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April 2019

FDA Public Meeting – Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities

April 29 @ 1:00 pm - 5:00 pm
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993 United States
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On Rare Disease Day, FDA announced the Agency will host a public meeting - “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities” on April 29, 2019. The purpose of the meeting is to obtain patients’ and caregivers’ perspectives on the impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. Patients and caregivers are strongly encouraged to participate either in-person or remotely. Date: Monday,…

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