The Center for Drug Evaluation and Research (CDER) Center for Real-World Evidence Innovation (CCRI) is the focal point to promote more efficient and consistent communication across […]

Reference #: FEI 2411192 Product: Drugs Recipient: Recipient Name Mr. Zachary Julius Recipient Title CEO Professional Disposables International, Inc. 4855 Pine Tree DriveMiami Beach, FL 33140United […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Zachary Julius Recipient Title Chief Executive Officer Professional Disposables International, Inc. 2 Nice-Pak ParkOrangeburg, NY 10962-1317United […]

12-12-2024 FDA Drug Safety Communication Drug Safety Communication (PDF – 221 KB) Based on its review of postmarket clinical trial data, the U.S. Food and Drug […]

FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with use of Ocaliva reported in the FDA Adverse Event […]

[12/12/2024] AUDIENCE: Gastroenterology, Hepatology, Patient, Health Care Professional, Pharmacy ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis […]

Update: FDA was informed in late 2022 that the current supplier of domperidone was exiting the business due to transfer of ownership of the product to […]

For Immediate Release: December 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

The U.S. Food and Drug Administration is responsible for protecting the public health through the rigorous review of applications for licensure of biological products, including biosimilar […]