How to Navigate CDER Workshops for Advocacy Groups
CDER and You: Keys to Effective Engagement
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) conducted a public workshop entitled “CDER and You: Keys to Effective Engagement.” This marked the third annual CDER public workshop for patient advocacy groups. It built upon previous efforts to help advocates understand how they can engage with the FDA to enhance drug development and safety.
DATE, TIME, AND LOCATION
April 3, 2018, from 9 a.m. to 3 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 (The Great Room A, B, and C)
Silver Spring, MD, 20993
Meeting Agenda
- Meeting Agenda (PDF - 131KB)
- Presentation Slides (PDF - 5.74MB)
Meeting Materials
- Transcript (PDF - 2.98MB)
- Collecting Patient Experience Data: How You Can Best Help FDA (PDF - 1.18MB)
- Supporting Rare Disease Drug Development: CDER’s Rare Diseases Program (PDF - 572KB)
- Understanding the Needs of CDER Drug Review Divisions (PDF - 421KB)
- What CDER Can and Can’t Do (PDF - 627KB)
- Rocking the Docket (PDF - 192KB)
- Externally-Led Patient-Focused Drug Development (PFDD) Meetings (PDF - 478KB)
- FDA Patient Affairs (PDF - 131KB)
- Office of Health & Constituent Affairs’ Patient Representative Program (PDF - 665KB)
- CBER Patient Engagement (PDF - 321KB)
- Learn from the Pros – Platelet Disorder Support Association (PDSA) (PDF - 114KB)
- Learn from the Pros – Depression and Bipolar Support Alliance (DBSA) (PDF - 210)
Links to CDER and You: Keys to Effective Engagement Public Workshop held on April 3, 2018
- Morning: https://collaboration.fda.gov/p2mncnahbz8/
- Mid-day: https://collaboration.fda.gov/p7t3lplmhnt/
- Afternoon: https://collaboration.fda.gov/p2zeqth38a6/
Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), sponsored a public workshop entitled “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research.” The purpose of this public workshop was to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.
DATE, TIME AND LOCATION
May 12, 2017, from 9 a.m. to 3 p.m
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 (The Great Room A, B, and C)
Silver Spring, MD, 20993
Meeting Agenda
- Agenda (PDF - 311)
- Roadmap for Engaging with FDA’s CDER Public Workshop transcript from May 12, 2017 (PDF - 365KB)
Meeting Materials
- NDA at the FDA (PDF – 1.8MB)
- Rocking the Docket (PDF - 161KB)
- Measuring How Patents Feel and Function (PDF – 1.1MB)
- Supporting Rare Disease Drug Development: CDER Rare Disease Program (PDF - 434KB)
- Discussion Panel: How to Get Your Voice Heard
- Knowing the Moment It Happens: CDER Social Media Program (PDF – 1.89MB)
- Learn from the Pros
Links to Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research held on May 12, 2017
- Part 1: https://collaboration.fda.gov/p21qfa2jb3y/
- Part 2: https://collaboration.fda.gov/p3qpazlnuup/
- Part 3: https://collaboration.fda.gov/p3iwkbtqz5k/
FOR FURTHER INFORMATION CONTACT
CONTACT: NAV-CDER@fda.hhs.gov.
TRANSCRIPTS
A transcript of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop. Transcripts will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at http://www.fda.gov.
Navigating CDER: What You Should Know for Effective Engagement
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), sponsored a public workshop entitled “Navigating CDER: What You Should Know for Effective Engagement.” The purpose of this public workshop was to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.
FDA Voice Blog: A 'Roadmap' for Navigating Patient Advocacy
DATE, TIME AND LOCATION
March 31, 2016, from 8:30 a.m. to 5 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
The Great Room (Room A, B and C)
Silver Spring, MD, 20993
Navigating CDER Transcript from March 31, 2016 Workshop (PDF - 718KB)
Meeting Materials
- Navigating CDER Folder Inserts (PDF - 7MB)
- Navigating CDER Agenda (PDF - 74KB)
- An NDA at the FDA (PDF - 2MB)
- Engagement with the FDA (PDF - 35KB)
- FDA Patient-Focused Drug Development (PDF - 340KB)
- CDRH Partnering with Patients (PDF - 2MB)
- Drug Availability Shortages and Demand (PDF - 520KB)
- Generic Drugs Busting the Myths (PDF - 1MB)
- Making Sure My Meds Are Safe (PDF - 892KB)
- Navigating CDER - Small Print - DDI (PDF - 1MB)
- ABCs of OTCs (PDF - 1MB)
- Learn from the Pros Stories of Engagement (PDF - 578KB)
Links to Navigating CDER Workshop held on March 31st
- https://collaboration.fda.gov/p5yghn2xkn4/
- https://collaboration.fda.gov/p38z8dv9jxg/
- https://collaboration.fda.gov/p2qwfb43a6i/
- https://collaboration.fda.gov/p3wdgd79uc9/
FOR FURTHER INFORMATION CONTACT
CONTACT: NAV-CDER@fda.hhs.gov.
TRANSCRIPTS
A transcript of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop. Transcripts will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at http://www.fda.gov.