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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 […]
October 28, 2020

Predator Nutrition – 607136 – 10/23/2020

Product: DrugsFood & Beverages WARNING LETTER Date: October 23, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you […]
October 28, 2020

Beepothecary LLC – 608383 – 10/23/2020

Product: DrugsFood & Beverages WARNING LETTER Date: October 23, 2020 TO: 3320 Toy RoadGroveport, OH 43125 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 […]
October 28, 2020

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

Summary Company Announcement Date: October 27, 2020 FDA Publish Date: October 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia […]
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