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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPTReject
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.