FDA Roundup: September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success
Coverage Analysis for Oncology SlidesDownload The post Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success appeared first on WCG. Source: Drug Industry Daily
Streamlining Site Feasibility and Start-up: Overcoming Challenges and Embracing Innovation in Clinical Research
In the ever-evolving landscape of clinical research, site feasibility and start-up processes remain critical yet challenging aspects that can significantly impact study timelines, costs, and overall success. In a recent…
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets…
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators
This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products for the treatment of cancer. Specifically,…
FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg Source: FDA Press…
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due…
BTS Research Successfully Completes USDA Inspection with Zero Findings
BTS Research Successfully Completes USDA Inspection with Zero Findings San Diego, CA - August 28, 2024 - BTS Research, a leading contract research organization specializing in preclinical research services, is…
Regulatory Update — Week of Sept. 9, 2024
This week, the FDA published three medical device classifications — clinical chemistry and clinical toxicology devices, gastroenterology-urology devices and immunology and microbiology devices. The agency also published draft strategy on…
Dealing With the Big Data Challenges Facing Industry Today
Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations…
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