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June 19, 2020

8th Annual Scientific Computing Days (SCD) – 09/29/2020 – 09/30/2020

On This Page Date: September 29 – 30, 2020 Time: 8:30 AM – 5:00 PM ET Image Summary: The FDA Scientific Computing Board (SCB) in partnership […]
June 19, 2020

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Summary Company Announcement Date: March 18, 2019 FDA Publish Date: March 18, 2019 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Presence of particulate […]
June 19, 2020

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

Summary Company Announcement Date: June 18, 2020 FDA Publish Date: June 18, 2020 Product Type: DrugsOver-the-Counter Drugs Reason for Announcement: Recall Reason Description Incorrect dosing cups […]
June 18, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 18, 2020

For Immediate Release: June 18, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 18, 2020

HIV and Hepatitis: Know Your Status and Learn About the FDA’s Role

Image Español April is National Minority Health Month. It’s a time to remember that health outcomes can be different among people of diverse ethnic and racial […]
June 18, 2020

FDA granted accelerated approval to tazemetostat for follicular lymphoma

On June 18, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or […]
June 18, 2020

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the […]
June 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020

For Immediate Release: June 17, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 17, 2020

Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program – 08/28/2020 – 08/28/2020

On This Page Date: August 28, 2020 Time: 8:30 AM – 12:30 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]
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