55 Matching Results

Search Results

Advanced search parameters have been applied.
in creator/contributor: "Thaul, Susan"  
Results: 1 - 24 next
open access

Smallpox Vaccine Injury Compensation

Description: This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
Date: June 13, 2003
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Pharmaceutical Supply Chain Security

Description: This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care,… more
Date: October 31, 2013
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Access to Unapproved Drugs: FDA Policies on Compassionate Use and Emergency Use Authorization

Description: This report discuses the approval or licensure procedures of drugs and biological products which Food and Drug Administration (FDA) may permit the sponsor to provide an unapproved or unlicensed product to patients outside the standard regulatory framework.
Date: August 4, 2015
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The report describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary. This report then presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children. It also analyzes the impact of BPCA and PREA have had on pediatric drug research.
Date: June 25, 2012
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Importing Prescription Drugs: Objectives, Options, and Outlook

Description: This report provides an overview about the Objectives, Options, and Outlook on Importing Prescription Drugs.it also examines the issues,spells out how they are treated from bill to bill, and refer to alternatives to important to ease the burden of prescription drug.
Date: January 26, 2007
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, … more
Date: December 2, 2008
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Vaccine Policy Issues

Description: This report’s focus is on vaccination, one of the most cost-effective methods available to prevent infectious diseases. Whether a vaccine’s target is naturally occurring or present because of hostile intent, the issues policymakers must deal with include vaccine development, production, availability, safety, effectiveness, and access. Vaccines are biologics: their basic components begin as a living material. They introduce bacteria or dead or weakened viruses into a person or animal to stimulat… more
Date: May 19, 2005
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
Back to Top of Screen