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 […]
May 8, 2024
The Generic Drug User Fee Amendments of 2012 (GDUFA) was designed to speed access to safe and effective generic drugs to the public and reduce costs […]
May 8, 2024
Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
May 8, 2024
TOPLINE: Nearly 90% of adults were at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome between 2011 and 2020, according to new research published in JAMA. METHODOLOGY: In […]
May 8, 2024
A risk score incorporating genetic variants for open-angle glaucoma is accurate enough to help with diagnosis of the condition, an interim study reveals. Although hundreds of […]
May 8, 2024
Cardiovascular disease management is an often overlooked but critical aspect of care for people with type 1 diabetes, authors of a new review paper said. Cardiovascular […]