June 3, 2022

Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites – 07/19/2022

On This Page Date: July 19 – 20, 2022 Day1: Tue, Jul 19 9:10 AM – 4:10 PM ET Day2: Wed, Jul 20 9:10 AM – […]
June 2, 2022

Mixing Medications and Dietary Supplements Can Endanger Your Health

Image Español When you take prescription or over-the-counter (OTC) medications, do you also take a vitamin, mineral, or other dietary supplement? Have you considered whether there […]
June 2, 2022

Anidulafungin Injection

Recognized Interpretive Criteria Minimum Inhibitory Concentrations(mcg/mL)Broth Microdilutionat 24 Hours Disk Diffusion(zone diameters in mm)Disk Diffusion at 24 Hours Pathogen S I R S I R Candida […]
June 1, 2022

Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients

Summary Company Announcement Date: May 28, 2022 FDA Publish Date: May 28, 2022 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Contains diclofenac Company […]
June 1, 2022

Ukoniq (umbralisib): Drug Safety Communication – FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

[Posted 06/01/2022]  AUDIENCE: Oncology, Patient, Health Professional, Pharmacy    ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from […]
June 1, 2022

Rationale for FDA’s Position on Oxacillin Breakpoints for Staphylococcus

Oxacillin is approved for the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to this antibacterial drug. In 2017, the Clinical Laboratory […]
June 1, 2022

FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns

Drug Safety Communication (PDF – 197 KB) 6-1-2022 FDA Drug Safety Communication Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its […]
May 31, 2022

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular […]
May 31, 2022

FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications

On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma […]
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