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 […]

The bioassay initiative: enhanced biosimilar testing capabilities OPQ/OPQR May 2023 2-3 years Research Priority C: Define best-practices for assessing and reporting quality attributes Enhancing CDER bioassay capabilities to […]

Delivery Method: VIA UPS Reference #: 320-25-20 Product: Drugs Recipient: Recipient Name Dr. Pooneh Ramezani, DDS, Dr. Paris Sabo, MD Recipient Title Owners Dr. Brite, LLC […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-15 Product: Drugs Recipient: Recipient Name Mr. Nelson Wan Recipient Title Official Correspondent Guangzhou Four E’s Scientific Co., Ltd. […]