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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

Dosing Our pharmacy services can prepare liquid, solid, and intravenous dosage formulations. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. To accomplish this, we pay careful attention to both dosing and sample collection.

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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

The Pharma Data

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

This critical task requires meticulous planning and rigorous procedures to avoid any hazards potentially arising during the journey of an IP from the controlled environment of a pharmacy or preparation room to its destination. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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Warning of counterfeit ivermectin tablets sold via social media

Sciensano

Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021. Pharmacies that sell medicines online must display the European logo for Internet pharmacies on every page of their website.