FDA clinical trials drug accountability

FDA clinical trials drug accountability

An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes. When drug accountability records are well designed…
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Clinical trials applications FDA

Clinical trials applications FDA

When designing clinical trials,it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies,guidances,and regulations…
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Phases clinical trials FDA

Phases clinical trials FDA

A new treatment goes through several phases. Each phase has a different purpose: Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also…
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FDA clinical trial endpoints guidance

FDA clinical trial endpoints guidance

This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the Agency s current thinking regarding designs of clinical trials…

Ximelagatran and clinical trials and FDA

Ximelagatran and clinical trials and FDA

Objective: In clinical trials, the efficacy and safety of the oral direct thrombin inhibitor ximelagatran have been evaluated in the prevention or treatment of thromboembolic conditions known to have high morbidity and mortality. In these studies, raised…

FDA Regulations For clinical trials

FDA Regulations For clinical trials

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input from interested persons on FDA s scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated…

FDA medical device clinical trials Regulations

FDA medical device clinical trials Regulations

Moderator: Heather Howell Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode. During the question-and-answer session, please press star 1 on your touch-tone phone. Today’s conference is being recorded…

FDA HIFU clinical trials

FDA HIFU clinical trials

Treatment Customization Due to the precision and flexibility of Sonablate HIFU, patients with their physician can decide on a customized treatment plan tailored to their prostate cancer diagnosis. Below is a summary of the different levels of customization…

FDA clinical trials Geron

FDA clinical trials Geron

Geron Corporation’s (GERN - Analyst Report) shares plunged 61.6% on news that the FDA has placed a full clinical hold on the company’s only pipeline candidate, imetelstat. What is a Clinical Hold? A clinical hold is an order issued by the FDA under which…

FDA clinical trials website

FDA clinical trials website

Complaints related to FDA-regulated clinical trials should be reported to the office handling the type of study involved: Biologics studies (including gene therapy and vaccine studies): Call 301-827-6221 Fax 301-827-6748 Email: ocod@fda.hhs.gov (Division…

Vaccine clinical trials FDA

Vaccine clinical trials FDA

FDA Center for Biologics Evaluation and Research (CBER) has awarded a cooperative agreement grant in the amount of $780, to the World Health Organization (WHO) on September 5, 2012. The project represents collaborative efforts between FDA and the WHO…