Docket Number: FDA-2016-D-0236 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist applicants of new drug […]
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of new drug applications (NDAs) with the development […]
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical development of drugs […]
The list of DMFs, which is updated quarterly, contains DMFs RECEIVED by March 31, 2024, for which acknowledgment letters were sent before April 10, 2024. The […]
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]
Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]
The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications: […]
For Immediate Release: April 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, […]
Biosimilars Basics for Patients Approval, labeling, side effects, and safety Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful Buying & Using Medicine Safely […]
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