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October 30, 2020

Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

Introduction On August 6, 2020, the President issued an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. […]
October 29, 2020

FDA Adverse Event Reporting System (FAERS) Public Dashboard

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention […]
October 29, 2020

2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee | FDA In this section: Peripheral and Central Nervous System Drugs Advisory Committee Home Advisory […]
October 29, 2020

Electronic Submissions Presentations

PharmaSUG, Single Day EventOctober 23, 2020 Electronic Submissions Update – from eCTD to CDISC Implementation and Beyond, Ethan Chen, Division of Data Management Services & Solutions, Office […]
October 29, 2020

2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee

2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee | FDA In this section: Peripheral and Central Nervous System Drugs Advisory Committee Home Advisory […]
October 29, 2020

UPDATED TIME AND PUBLIC PARTICIPATION INFORMATION: December 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 12/15/2020 – 12/15/2020

On This Page Date: December 15, 2020 Time: 9:00 AM – 5:00 PM ET UPDATED INFORMATION (as of 10/28/2020): The public participation information has been changed […]
October 29, 2020

November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 11/02/2020 – 11/02/2020

On This Page Date: November 2, 2020 Time: 9:00 AM – 1:00 PM ET Center Date Time Location CDER November 2, 2020 9 a.m. to 1 […]
October 28, 2020

Coronavirus (COVID-19) Update: October 28, 2020

For Immediate Release: October 28, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
October 28, 2020

A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications

CDER researchers are investigating how drug characteristics, regulatory actions, and economic factors influence whether generic drugs become available for a brand-name drug. High prices for prescription […]
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