Drug Approval

Regulatory Issues for Approval: File IND/Clinical

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Regulatory Issues for Approval: File IND/Clinical Studies, File NDA, and Other Approval

Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.

VII. Influential Scientific, Financial, and

HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. VII. Influential Scientific, Financial, and Statistical Information

As illustrated by the number and types of information we disseminate and the variety of methods we use to disseminate them, it is clear that we strive for a high degree of transparency with regard to all of our information dissemination activities. The OMB Guidelines, however, apply special quality standards to the dissemination of information tha

V. Agency Quality Assurance Policies, Standards,

HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. V. Agency Quality Assurance Policies, Standards, and Processes

As described in the HHS Implementation Plan, as one of the HHS operating divisions, we have established a number of quality assurance policies, standards, and processes for ensuring the quality of the information we disseminate to the public. Our documents undergo a rigorous review and clearance evaluation according to pre-established procedures,

HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. III. Types of Information Disseminated

We make a large number of documents and information available to a variety of audiences. The major types, with examples of each, are provided here. Public Communications About Risk As part of our mission to protect the public health and safety, we provide the public with a wide variety of information on risk, including information on food

HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public

This site describes the HHS Information Quality Guidelines as well as the supporting administrative mechanisms to request correction of information covered under the guidelines. The HHS Guidelines were developed in accordance with the provisions of P.L. 106-554 and OMB government-wide requirements directing all federal agencies to issue guidelines

Examination of Clinical Trial Costs and Barriers for Drug Development. E.3.6 Drug Sponsor-Imposed Barriers

Excessive risk-aversion leads to unnecessary steps being taken. In multicenter trials, uncertainty and inconsistent enrollment success across sites creates a need to over-enroll and plan trials “defensively.” Internal review processes for organizations conducting/sponsoring clinical trials can delay a trial’s start.

Examination of Clinical Trial Costs and Barriers for Drug Development. 6 References

Adams, C., & Brantner, V. (2006). Estimating The Cost Of New Drug Development: Is It Really $802 Million? Health Affairs, 25 (2). Adams, C., & Brantner, V. (2010). Spending on new drug development. Health Economics , 19(2), 130- 141. Angell, M. (2004). Introduction: Drugs are Different. In M. Angell, The Truth About the Drug Comp

Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6.3 Data and Site Monitoring

Data and site monitoring costs are another key barrier that is largely self-imposed by sponsors. In general, industry-sponsored trials are monitored by individuals who visit sites at intervals defined by their company standard operating procedure (SOP) or study-specific monitoring plan. The pharmaceutical industry estimates that monitoring can acc

Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6.2 Study Design

Enrollment Restrictions

Examination of Clinical Trial Costs and Barriers for Drug Development. 1 Introduction and Background

In calendar year 2012, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 39 novel new drugs (i.e., new molecular entities (NMEs) and new biological entities (NBEs), including both novel drugs and biologics). 1 While 39 approvals marks the highest number of NMEs/NBEs approved since 2004, drug companies are

Analytical Framework for Examining the Value of Antibacterial Products. 7 References

About NIAID . (2012, February 29). Retrieved November 12, 2012, from National Institute of Allergy and Infectious Diseases: http://www.niaid.nih.gov/about/pages/default.aspx Aldy, J. E., & Viscusi, W. K. (2008). Adjusting the Value of a Statistical Life for Age and Cohort Effects. The Review of Economics and Statistics, 90 (3), 573–581

Analytical Framework for Examining the Value of Antibacterial Products. 2.1.3 Modifications to the Clinical Trial Process and Approval Standards

This incentive encompasses a number of ideas intended to streamline the clinical trial and drug approval processes for antibacterial drugs in order to shorten the timelines and, in turn, reduce the costs associated with developing these drugs. Easing the development requirements could reduce development costs by shortening the time to market for

Performance Improvement 2007. Chapter I – Overview of Completed Evaluations—Selected Highlights

Chapter I presents highlights from the findings of the studies included in this Performance Improvement 2007 report. These examples were selected to emphasize the breadth of subject areas addressed by the studies and showcase the diverse methodologies used.

Performance Improvement 1998. Food and Drug Administration

MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation. Evaluation Program

Performance Improvement 1998

Performance Improvement 1998 is the third annual report of the U.S. Department of Health and Human Services (HHS) on its evaluation activities. As a report to Congress, it summarizes the findings of HHS evaluations completed in fiscal year (FY) 1997. In that year, HHS agencies produced 155 evaluation reports and supported more than 335 evaluation

Examination of Clinical Trial Costs and Barriers for Drug Development

Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes. Improving the drug development process

rpt_erg.pdf
PDF

Analytical Framework for Examining the Value of Antibacterial Products

Antibacterial resistance is a growing global problem. At least 2 million people in the U.S. acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat it. Despite the potential of new antibacterial products to reduce the social burden associated with resistant infections, development of

rpt_antibacterials.pdf
PDF

Performance Improvement 2007

This Performance Improvement 2007 report provides a brief summary of each of the evaluations completed by the Health and Human Services (HHS) during Fiscal Year 2006 (October 1, 2005 to September 30, 2006). All Performance Improvement reports, the full database of summaries or abstracts of the more than 8,000 current, ongoing, and past studies, an

PerformanceImprovement2007.pdf
PDF

Content by Keyword: Drug Approval

rpt_erg.pdf

rpt_antibacterials.pdf

PerformanceImprovement2007.pdf