Drug Review Process Research Articles

Impact of Policy Research on Drug Development Strategies

Policy research examines, among other things, factors related to the development and review of new drugs, allowing one to assess the overall outcome of the processes involved therein. Results of this research may directly influence development strategies. For example, data on relative development times of drugs in different therapeutic classes may constitute incentives for pursuing drug development in some therapeutic areas and disincentives in others. As another example, data on the average length of time required for approval of second or further indications for already approved drugs may dissuade a sponsor from initiating supplemental indication research, especially when taken in conjunction with the deterioration of patent protection time and the growth of generic prescribing. These and other policy data related to the drug development and review processes are presented, and their impact on development strategies is discussed.

Monitoring antibiotic usage in the hospital.

The authors outline the quality indicators being developed by the Joint Commission on Accreditation of Health Care Organizations to compare hospital performance. The Joint Commission has provided several incentives to encourage antibiotic monitoring based on criteria derived from standard practice, as defined in the literature, and on the clinical judgment of the medical staff. In addition, the drug review process should be continuous and should encompass all areas of drug use in the hospital, including effectiveness in terms of disease outcome as well as cost efficiency. The authors discuss procedures under development in their institution to promote cost efficiency and informed discussion regarding clinical use of antibiotics on the formulary. Microbiology reporting, drug use, requests for nonformulary drugs, and unusual patterns of infection and sensitivities are tracked to identify problem areas and a feedback loop is used to inform the medical staff.

The drug review process in Sri Lanka.

The drug review process in Sri Lanka.

FDA's drug review process is focus of attention in 1987; agency approves 27 new products

FDA's drug review process is focus of attention in 1987; agency approves 27 new products

The drug review process in the Netherlands Antilles.

The drug review process in the Netherlands Antilles.

Drug review, approval process changing

The FDA made news this year when it put into effect substantial revisions of the regulations that govern the drug review and approval process. The revisions have altered the way drug manufacturers submit marketing applications, making them smaller and more focused on the needs of particular reviewers; emphasized the FDA's willingness to rely on good foreign data; required that the safety part of pending marketing applications be updated while the applications were under review; and, in general, were designed to make the review process more efficient without impairing its quality. The operating units of the FDA most affected by the new regulations, says Robert J. Temple, MD, director of the Office of Drug Research and Review, are his office and its counterpart for biologics, the Office of Biologics Research and Review. These two units are responsible for the evaluation and approval or nonapproval of all new drugs and biologics. When

The Anda Submission and Review Process

AbstractA summary of the Abbreviated New Drug Application (ANDA) submission and review process is presented. The numerous significant factors that have impacted the process are highlighted (e.g., the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, and the publication of the NDA rewrite), and the effects of these changes on ANDA submissions and the Division of Generic Drug’s policies and procedures are discussed. The criteria used in evaluating an ANDA submission in terms of acceptablity and completeness are set forth. Also, problems currently encountered in ANDA submissions are identified. Industry, FDA, and the public benefit when firms submit acceptable, complete ANDAs which can be processed expediently and culminate in approval.

FDA to Revise Drug Review Process

FDA to Revise Drug Review Process

The Development and Compilation of Chemical Information by the Bureau of Drugs Medical Library for the Drug Review Process

The Development and Compilation of Chemical Information by the Bureau of Drugs Medical Library for the Drug Review Process

Clinical Trials and the Drug Review Process

I would like to express my appreciation to the American College of Chest Physicians for inviting me to join you here today, to discuss certain issues bearing on the Food and Drug Administration and its performance. Certainly, we have many things to discuss.

Clinical trials and the drug review process

Clinical trials and the drug review process