0
ARTICLE |

The Drug Approval Process at the Food and Drug Administration:  New Biotechnology as a Paradigm of a Science-Based Activist Approach

Henry I. Miller, MD; Frank E. Young, MD, PhD
Arch Intern Med. 1989;149(3):655-657. doi:10.1001/archinte.1989.00390030115022.
Text Size: A A A
Published online

There are many stereotypes about bureaucrats. They have given rise, for example, to the quip about the most feared statement in the world, "I'm from the government, and am here to help." Our mail and professional contacts indicate that within the medical community, the mission, procedures, and capabilities of the Food and Drug Administration (FDA) are not well understood. This is especially unfortunate when increasing expectations are being placed on the FDA. Now perhaps more than ever, the FDA needs the active involvement of the medical community in conducting clinical trials, reporting adverse reactions, and educating patients on the availability and use of new therapies. In this article, we will relate how the FDA's recent drug review activities reflect a strong science base and an "activist" philosophy and use new biotechnology products as a paradigm of the agency's approach.

THE FDA'S HISTORY AND MANDATE  The FDA's roots lie deep in

Topics

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
/>
First page PDF preview

Figures

Tables

References

Correspondence

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 6

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Jobs
brightcove.createExperiences();