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Weekly LYN-005 Provides Sustained Risperidone Release in Schizophrenia

Physician's Weekly

WEDNESDAY, June 18, 2025 (HealthDay News) — For patients with schizophrenia, weekly LYN-005 provides sustained release of risperidone at therapeutic concentrations, according to a study published online June 11 in The Lancet Psychiatry. Leslie Citrome, M.D., for C min at week 1 and 1.04, 0.84, and 1.03 All rights reserved.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Discontinuation versus continuation of statins: a systematic review [Cardiovascular disease]

Annals of Family Medicine

Objective: To examine the impact of discontinuation of statins compared to continuation on clinical outcomes. Population Studied: Adults ≥18 years Intervention/Instrument: Discontinuation of statin medications Outcome Measures: All-cause mortality, cardiovascular (CV) mortality, and CV events (e.g., stroke and MI).

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Exploring the educational needs and preferences of physicians in pharmacogenomics in primary care practice [Education and training]

Annals of Family Medicine

Context Ten percent of patients using prescription drugs experience adverse drug events (ADE). A proportion of these ADEs can be explained by a difference in enzyme activity between individuals. Intra-individual variation in genetic composition is one of the key contributing factors determining enzyme activity.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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Green Practice News: April 2025

My Green Doctor

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. from 2000 to 2018 among people over 65 years old. Contact us today!

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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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