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March 12, 2020

CDER Manual of Policies & Procedures | MAPP

6702.1 Office of Surveillance and Epidemiology Risk Evaluation and Mitigation Strategy (REMS) Assessment Drug Safety 12/18/2019 6701.1 Office of Surveillance and Epidemiology Procedures for DMEPA Intra-Center […]
March 12, 2020

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

Image CaptionAttendees participate in this annual training course where they learn best practices for ensuring data quality and integrity in BSL-4 facilities. Current course | Background […]
March 11, 2020

January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 01/16/2020 – 01/16/2020

On This Page Date: January 16, 2020 Time: 8:00 AM – 5:00 PM ET Center Date Time Location CDER January 16, 2020 8:00 a.m. to 5:00 […]
March 11, 2020

Report | Drug Shortages: Root Causes and Potential Solutions

Drug Shortages: Root Causes and Potential Solutions, published in October 2019, examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug […]
March 11, 2020

Where and How to Dispose of Unused Medicines

Español Is your medicine cabinet full of expired drugs or medications you no longer use? Your medicine is for you. What’s safe for you might be […]
March 11, 2020

FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma

On March 10, 2020, the Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for […]
March 11, 2020

Drug Trials Snapshots: VYEPTI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 11, 2020

POSTPONED: March 11, 2020: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement – 03/11/2020 – 03/11/2020

On This Page Date: March 11, 2020 Time: 8:00 AM – 5:00 PM ET UPDATED INFORMATION (as of 3/9/2020): Due to extenuating circumstances, the Nonprescription Drugs […]
March 11, 2020

FDA Drug Safety Podcasts

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis March 4, 2020 […]
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