Policy developments in regulatory approval

@article{Temple2002PolicyDI,
  title={Policy developments in regulatory approval},
  author={Robert J. Temple},
  journal={Statistics in Medicine},
  year={2002},
  volume={21}
}
  • R. Temple
  • Published 15 October 2002
  • Medicine
  • Statistics in Medicine
Although radical changes in drug regulation are rare (e.g., the Federal Food, Drug and Cosmetic Act of 1938 and the 1962 amendment to the Act creating an effectiveness requirement), regulations and guidance do evolve significantly in the face of new problems and accumulating experience. Recent changes have been driven by the Food and Drug Administration Modernization Act (FDAMA), user fee legislation, the International Conference on Harmonization, recent safety related drug withdrawals, and… 
The Food and Drug Administration's Drug Safety Oversight Board: An Evolving Paradigm for Clinical Input on Drug Safety Topics
TLDR
The Drug Safety Oversight Board's membership includes members from three FDA centers and six other federal agencies that provide critical feedback on the impact and effectiveness of the FDA's actions and communications.
The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.
TLDR
The clinical trial endpoints that have been used to support approval in the oncology setting have evolved over the last 30 years commensurate with an improved understanding of the natural history of cancers and the mechanisms of action of drugs.
Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology
This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing
An international regulatory clinical trial comparative
TLDR
Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.
Gap in publication of comparative information on new medicines.
TLDR
Most of the main RaCTs, relevant for assessing the added value of a new medicine, are published subsequent to market entry; some of these trials remain unpublished; the authors argue for a standardized public registration of the results of themain premarketing clinical trials as a condition for market authorization.
Safety issues in cell-based intervention trials.
A brief review of Phase 1 and Clinical Pharmacology statistics in clinical drug development
Following a brief description of historical Phase 1 research, Clinical Pharmacology studies, and the role of statistics in this setting, Phase 1 study design and statistical analysis are reviewed. A
Bioequivalence: A Review of Study Design and Statistical Analysis for Orally Administered Products
TLDR
The international regulations for this purpose are described and an outline of major steps in the development of the bioequivalence two one-sided testing procedure is provided.
Dose Ranging Crossover Designs
Dose ranging trials are used frequently in drug development to learn about dose response for both desirable and undesirable effects and to provide sponsors with confidence that investment in
...
...

References

SHOWING 1-7 OF 7 REFERENCES
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues
TLDR
It is concluded that placebo-controlled trials may be ethically conducted even when effective therapy exists, as long as patients will not be harmed by participation and are fully informed about their alternatives.
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases
TLDR
It is concluded that placebo controls are ethical when delaying or omitting available treatment has no permanent adverse consequences for the patient and as long as patients are fully informed about their alternatives.
Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia
TLDR
Treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of my Cardiac Infarction.
Problems in interpreting active control equivalence trials.
  • R. Temple
  • Medicine
    Accountability in research
  • 1996