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CGMP Violations at Mexicos Betone SA de CV

[ Price : $8.95]

FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.

Multiple Agena Bioscience Violations

[ Price : $8.95]

FDA warns San Diego, CA-based Agena Bioscience about multiple violations in its manufacturing of a colon diagnostic panel as part ...

QS Issues in Beckman Coulter Inspection

[ Price : $8.95]

FDA warns Beckman Coulter about QS regulation violations at its Chaska, MN, manufacturing facility.

20 Safety Potential Signals in 4th Quarter 2023

[ Price : $8.95]

FDA posts 20 potential signals of serious risks/new safety information from the fourth quarter of 2023.

Bill to Speed Addiction Drug Treatments

[ Price : $8.95]

Rep. David Schweikert introduces legislation to require HHS to approve a fast-track designation for treatments for addictive subst...

Bioavailability/Bioequivalence Data Integrity Guide

[ Price : $8.95]

FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.

Mixed Data on Colon Cancer Vaccine

[ Price : $8.95]

Gritstone Bio reports mixed data from an ongoing Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantige...

Characterize Obesity as a Chronic Disease: Lilly

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Eli Lilly says any revision of an FDA guidance on weight management drugs should incorporate a modern scientific characterization ...

FDA Increasing Scrutiny of CooperSurgical IUD: Report

[ Price : $8.95]

A report by Spotlight on America suggests FDA is increasing scrutiny over CooperSurgical and its manufacturing facility in North T...

Guidance on Case Safety Report eSubmissions

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FDA posts a guidance entitled FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Repo...