[3-11-2024] Today, FDA issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. Once finalized, the guidance will provide recommendations to help […]

[03/15/2024] Today, FDA is announcing a new webpage to showcase how the agency uses one of its oversight tools, inspections, to help ensure drug safety and […]

[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development […]

What is mifepristone and how does it work? Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. […]

[10/17/2023] Today, CDER announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information […]

[10/31/2024] Today, the U.S. Food and Drug Administration is announcing approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). With this approval, […]

Aimovig (erenumab-aooe) Hypertension The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in April 2020 to include risk of […]

[4-7-2026] The Food and Drug Administration is advising consumers not to purchase or use Yeicob Ácido Hialurónico, a product promoted and sold for joint pain on […]

[4-7-2026] The Food and Drug Administration is advising consumers not to purchase or use KUKA FLEX CBD, a product promoted and sold for joint pain on […]