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Human Drugs

Illinois Jury Awards Man $3.2 Million in Androgel Suit

An Illinois federal jury finds AbbVie liable for injuries to an Oregon man allegedly caused by the companys testosterone replacement therapy AndroGel....

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/23/2018.

Federal Register

Info Collection Extension for In Vivo Radiopharmaceuticals Regs

Federal Register notice: FDA sends for OMB approval an information collection extension for Regulations for In Vivo Radiopharmaceuticals Used for Diag...

Human Drugs

Draft Guide on Bulk Substances for Drug Compounding

FDA issues a draft guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and C...

Medical Devices

Becton Dickinson Recalls Blood Collection Tubes

Becton Dickinson recalls its BD Vacutainer Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the sto...

Federal Register

Antimicrobial Drugs Panel Meeting on Achaogen NDA

Federal Register notice: FDA announces a 5/2 Antimicrobial Drugs Advisory Committee meeting on an Achaogen NDA for plazomicin.

Medical Devices

FDA Clears Auris Health Monarch Platform

FDA clears an Auris Health 510(k) for the Monarch Platform to assist with diagnostic and therapeutic bronchoscopic procedures for treating lung cancer...

Medical Devices

FDA Clears Delta Meds Closed System Catheter

FDA clears a Delta Med 510(k) for the DeltaVen Closed System Catheter.

Human Drugs

AbbVie Scraps Accelerated Approval for Lung Cancer Therapy

AbbVie decides to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung...

Federal Register

CBER Science Symposium Planned for June

Federal Register notice: FDA announces a 6/25-26 public symposium entitled 2018 Center for Biologics Evaluation and Research Science Symposium.