May 8, 2024
(Reuters) – Britain is refusing to sign the World Health Organization’s (WHO) pandemic accord because the country says it would have to give away a fifth […]
May 8, 2024
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
May 8, 2024
Strategic Plan CDER’s approach to data standards consists of four strategic goals: Support open, consensus-based data standards development Maintain and promote a well-defined data standards governance […]
May 8, 2024
Expanded Access (Compassionate Use) Submission Data Archive: CDRH CDER and CBER Archived Data (2010-2018) CDER and CBER Tables FY 2010 – 2018 Graphs of Expanded Access […]
May 8, 2024
The US Food and Drug Administration (FDA) has announced that Tandem Diabetes Care, Inc has issued a recall regarding version 2.7 of the Apple iOS t:connect […]
May 8, 2024
Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market […]
May 8, 2024
On This Page Date: June 18, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT The […]
May 8, 2024
Use the QR Code to Verify an Electronic Certificate of Pharmaceutical Product Electronic certificates of pharmaceutical product (eCPP) include a unique quick response (QR) code. This […]
May 8, 2024
FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA. Minutes from these meetings are posted on […]
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