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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsFDA Rare Disease Day 2020:
Supporting the Future of Rare Disease Product Development

Meeting Date: 2/24/20-2/24/20

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Meeting Details:

The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholder’s perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.

 

       
Location: FDA White Oak | Great Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 2/26/20-2/26/20

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Meeting Details:

During the morning session, the committee will discuss new drug application 212578 for padeliporfin di-potassium powder for solution for injection, submitted by STEBA Biotech, S.A. The proposed indication (use) for this product is for the treatment of patients with localized prostate cancer, meeting the following criteria: Stage T1-T2a and prostate specific antigen less than or equal to 10 ng/mL and Gleason Grade Group 1 based on transrectal ultrasound guided biopsy or unilateral Gleason Grade Group 2 based on multiparametric magnetic resonance imaging-targeted biopsy with less than 50 percent of cores positive. During the afternoon session, the committee will discuss supplemental biologics license application 125477/S-034, for CYRAMZA (ramucirumab) injection for intravenous use, submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with erlotinib, for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/20-3/4/20

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Meeting Details:

On March 4, 2020, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:30AM-5:10PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 3/11/20-3/11/20

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Meeting Details:

In the Agency's document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, 2018, 83 FR 63168) (Docket No. FDA-2018-N-3458), FDA sought input on the current use of over-the-counter antiseptics in the food handler setting and the recommended testing criteria to establish the safety and effectiveness of these products. Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsTobacco Products Scientific Advisory Committee Meeting

Meeting Date: 2/14/20-2/14/20

Meeting Details:

On February 14, 2020, the Center for Tobacco Products (CTP) Tobacco Products Scientific Advisory Committee (TPSAC) will meet in open session to discuss discuss the modified risk tobacco product applications, submitted by 22nd Century Group Inc. for the following combusted filtered cigarette tobacco products: MR0000159: VLNTM King MR0000160: VLNTM Menthol King

 

       
Location: The Great Room FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsThe Oncology Center of Excellence (OCE)
Envisioning Oncology Product Development for 2025

Meeting Date: 2/5/20-2/5/20

Meeting Details:

The Oncology Center of Excellence (OCE), Envisioning Oncology Product Development for 2025

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

There are no Live Broadcasts available at this time.