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July 29, 2022

Planning an EL-PFDD Meeting

What should stakeholders consider when deciding to pursue an externally-led PFDD meeting? Given the expanse of diseases affecting the U.S. patient population and the effort required […]
July 29, 2022

DOJ Reportedly Opens Criminal Inquiry Into Alzheimer’s Research DOJ Reportedly Opens Criminal Inquiry Into Alzheimer’s Research

The US Department of Justice (DOJ) has reportedly opened a criminal investigation into Cassava Sciences just 1 week after a neuroscientist alleged in an expose that the […]
July 29, 2022

HIV Patient With Prolonged Remission May Open Avenue to Cure HIV Patient With Prolonged Remission May Open Avenue to Cure

The case of a patient in an HIV study whose viral load dropped to undetectable levels and whose immune cells soared has captured the attention of […]
July 29, 2022

Do ICDs Still Work in Primary Prevention Given Today’s HF Meds? Do ICDs Still Work in Primary Prevention Given Today’s HF Meds?

Contemporary guidelines highly recommend patients with heart failure with reduced ejection fraction (HFrEF) be on all four drug classes that together have shown clinical clout, including […]
July 29, 2022

Drug Development and Drug Interactions | Table of Substrates, Inhibitors and Inducers

CYP Enzymes In vitro Clinical index drugs Examples of clinical substrates, inhibitors, and inducers Transporters In vitro Examples of clinical substrates, inhibitors and inducers Table 1-1: […]
July 29, 2022

Malpractice Lawyer Gloats at Win, Then Puts Foot in Mouth Malpractice Lawyer Gloats at Win, Then Puts Foot in Mouth

During the closing arguments in a $10 million malpractice trial, attorney Robert McKenna III told jurors the claims against his client, a gastroenterologist, were baseless and […]
July 29, 2022

Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance […]
July 29, 2022

Most Health Execs Lack Formal Plan to Achieve Care Equity: Survey Most Health Execs Lack Formal Plan to Achieve Care Equity: Survey

Despite most healthcare executives acknowledging the importance of health equity for their patient populations, most have no idea how to accomplish it, according to recent survey […]
July 29, 2022

New Blood Test Could Reshape Early CRC Screening New Blood Test Could Reshape Early CRC Screening

A simple blood test that looks for a combination of specific RNA snippets may become a novel way to screen for early-onset colorectal cancer, suggests a […]
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