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Some Remarks about “Approval”
The government extensively controls the system of drug development, production, and usage. In exercising control, the government apparatus develops and institutionalizes a vocabulary. Terms...
The Drug Development and Approval Process
The process of getting a drug to market, from first testing to final FDA approval, is summarized in figure 1 and described at greater...
Some Remarks about “Safety”
The term safety is often used in a simplistic and misleading manner. Safety depends on many particulars of the individual case. For example, one...
Theory, Evidence and Examples of FDA Harm
To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often...
Why the FDA Has an Incentive to Delay the Introduction of New Drugs
FDA drug reviewers are immune from legal liability, but they may be reproached and humiliated by congressional hearings, television exposés, and newspaper condemnations. Why...
Where Is the Market Failure Argument for the Interventions We Have?
According to the Food and Drug Administration (FDA), some 20 cents of every consumer dollar purchases products that come under the purview of the...
Some Remarks about Medical Devices
Medical devices came under official FDA control in 1976 with the Medical Device Amendments. The definition of medical devices encompasses everything from tongue depressors...
Reform Options
In recent years, some welcome FDA reform has occurred, particularly with the PDUFA of 1992 and the 1997 Modernization Act. The significant component of...
The Sensible Alternative: The Voluntary Provision of Assurance
We believe that it would be desirable to move toward a voluntary system in which private firms, organizations, and perhaps also other governments and...
Glossary
Abbreviated New Drug Application (ANDA)
The ANDA was established by the Waxman-Hatch Act. Under an ANDA, proof of bioequivalence is enough to satisfy FDA safety...