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February 17, 2023

UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) – 06/17/2020

On This Page Date: June 17 – 18, 2020 Time: 10:00 AM – 3:30 PM ET UPDATED INFORMATION (as of 6/2/2020): The Agenda portion has been […]
February 17, 2023

February 26, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 02/26/2020

On This Page Date: February 26, 2020 Time: 8:00 AM – 5:00 PM ET Center Date Time Location CDER February 26, 2020 8:00 a.m. to 5:00 […]
February 17, 2023

UPDATED PUBLIC PARTICIPATION INFORMATION: December 18, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 12/18/2019

On This Page Date: December 18, 2019 Time: 8:00 AM – 12:30 PM ET UPDATED INFORMATION (as of 12/6/2019):The morning session of the Oncologic Drugs Advisory […]
February 17, 2023

UPDATED PUBLIC PARTICIPATION INFORMATION: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 12/17/2019

On This Page Date: December 17, 2019 Time: 8:00 AM – 5:00 PM ET UPDATED INFORMATION (as of 12/4/2019):The public participation information has been changed for […]
February 17, 2023

FDA approves first enzyme replacement therapy for rare alpha-mannosidosis

Action FDA has approved Lamzede (velmanase alfa), the first enzyme replacement therapy approved in the U.S. for the treatment of the non-neurological effects of alpha-mannosidosis, a […]
February 17, 2023

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

Submit Comments by 04/22/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
February 17, 2023

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy – 610384 – 02/13/2023

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Dawn T. Hoang Recipient Title Co-Owner First Royal Care Co. LLC, dba Red Mountain Compounding […]
February 16, 2023

Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose – 03/08/2023

On This Page Date: March 8 – 9, 2023 Day1: Wed, Mar 8 1:00 PM – 4:45 PM ET Day2: Thu, Mar 9 1:00 PM – […]
February 16, 2023

June 20, 2019: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee – 06/20/2019

On This Page Date: June 20, 2019 Time: 9:00 AM – 3:30 PM ET UPDATED INFORMATION: (as of May 24, 2019)The meeting time, agenda, and public […]
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