Sputtr.com | Alternative Search Engine

Investigational

INVESTIGATIONAL DRUGS FOR HUMAN USE I. PURPOSE

Policy and Procedure Investigational Drugs for Human Use Policy #55 August 2007 INVESTIGATIONAL DRUGS FOR HUMAN USE . I. PURPOSE: To delineate policies and procedures relating to the safe handling, dispensing,

Guidance for Industry

Guidance for Industry CGMP for Phase 1 Investigational Drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA) July 2008 CGMP

NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING ...

(FDA 21 CFR 50, ICH 6A). 2.1.12 Investigational Device Exemption (IDE): An IDE allows the investigational device to be used in a clinical protocol in order to collect safety and effectiveness data required to support a Premarket Approval ...

POLICIES & PROCEDURES

Duke University Medical Center Approved by: Steve Dedrick INVESTIGATIONAL DRUG SERVICE Department of Pharmacy Effective Date: 01/07 Policy Expiration Date: 01/10 POLICIES & PROCEDURES Archive Date: Page 1 of 2 http://Pharmacy. mc.duke.edu I. POLICY A.

Title: INVESTIGATIONAL DRUG HANDLING

Medical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0 Effective Date: 09/12/06 1 Developed by the Office of Human Research Protection (OHRP) Clinical Research SOP Workgroup Title: INVESTIGATIONAL DRUG HANDLING 1.0 OBJECTIVE: 1.1 This SOP describes the ...

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

The mode of action of the investigational medicinal product, findings in the non-clinical toxicity studies and any anticipated responses should be used to identify likely adverse reactions.

Corporate Medical Policy

Corporate Medical Policy Investigational (Experimental) Services File Name: investigational_ (experimental)_services Origination: 1/1996 Last Review: 09/28/2009 Active policy, no longer scheduled for routine review.

Advanced Practice Programs in Hospital Pharmacy ...

Hospital Pharmacy 143 Director's Forum INTRODUCTION Hospitals can be primary cent ers for clinical research investigat ions on new or investigational drugs; it is likely that hospital pharmacists will at some time be involved in the handling of these special drugs.

Draft Guidance for Industry and Food and Drug Administration ...

Draft Guidance for Industry and Food and Drug Administration Staff . The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)

Coverage of Experimental and Investigational Procedures

Coverage of Experimental and Investigational Procedures Policy Aetna covers experimental or investigational technologies (i.e., drugs, procedures and devices) when ALL of the following criteria are met.