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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

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

Bioavailability/Bioequivalence Data Integrity Guide

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FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.

Mixed Data on Colon Cancer Vaccine

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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

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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...

Guide on Oxymetazoline HCl ANDAs

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Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.

FDA Developing New Drug Safety Tools: Dal Pan

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CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says FDA is developing new tools to help identify drug pos...

Baxter Novum IQ Large Volume Pump Cleared

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FDA clears a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump with Dose IQ safety software.