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September 3, 2021

Human Drug Export Certificate Application Instructions

Facilities may request a certificate of pharmaceutical product or CGMP declaration using the CDER export certification and tracking system (CDEReCATS). CDEReCATS offers several benefits, including a possible […]
September 3, 2021

October 28, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 10/28/2021 – 10/28/2021

On This Page Date: October 28, 2021 Time: 10:30 AM – 3:00 PM ET Center Date Time Location CDER October 28, 2021 10:30 a.m. to 3:00 […]
September 3, 2021

247rxpill.in – 615313 – 08/31/2021

Product: Drugs Recipient: 247rxpill.in United States Issuing Office: Center for Drug Evaluation and Research | CDER United States TO: 247RX‐PILL FROM: The United States Food and […]
September 3, 2021

PowerAll Pharma – 615216 – 08/31/2021

Product: Drugs Recipient: PowerAll Pharma United States Issuing Office: United States TO: PowerAll Pharma FROM: The United States Food and Drug Administration RE: Causing the Introduction […]
September 2, 2021

Janus Kinase (JAK) inhibitors: Drug Safety Communication – FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death

AUDIENCE: Patient, Rheumatology, Gastroenterology, Cardiology, Neurology, Oncology, Pharmacy, Health Professional   ISSUE: The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), […]
September 2, 2021

About the FDA and How Can You Get Involved

Patient questions and answers: Download and share Patients are at the heart of the FDA’s mission. The FDA protects public health by enforcing laws and regulations […]
September 2, 2021

FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research

Image By: William Slikker, Jr., Ph.D., National Center for Toxicological Research Director and RADM Denise Hinton, Chief Scientist The U.S. Food and Drug Administration is responsible […]
September 2, 2021

Best Practices for Development and Application of Disease Progression Models – 11/19/2021 – 11/19/2021

On This Page Date: November 19, 2021 Time: 9:30 AM – 2:30 AM ET The Food and Drug Administration (FDA) Center for Drug Evaluation and Research […]
September 1, 2021

FDA approves zanubrutinib for Waldenström’s macroglobulinemia

On August 31, 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), […]
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