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. […]

[12-06-2024] The Food and Drug Administration is advising consumers not to purchase or use Fouzee SugarLin Herbal Formula, a product promoted and sold as a glucose […]

ACTIONS BY MONTH Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24 Jul-24 Aug-24 Sep-24 FY-2024 Approvals 57 51 53 56 52 48 65 71 50 […]

For Immediate Release: December 06, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, […]

Docket Number: FDA-2018-D-0481 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or the Agency) is announcing the […]

Submit Comments by 02/04/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not […]