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on the regulatory advisors. In fact, reproach later will deter the critical assistance from the FDA that can be so very helpful to a drug development team. |
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These impressions, of course, need to be modified in the context of the divisions and the individuals involved. There are differences among and between divisions, individuals, and those at FDA giving advice, and this needs to be factored into the equation. But clearly the most successful in development have created a working relationship with the FDA and made use of the extensive scientific experience these individuals have with drug development. Having been the organizer of a course on Cardiovascular Drug Development, Protocol Design, and Methodology for 15 years, I can attest to the unselfish assistance of so many senior individuals at the FDA. Their knowledge of the drug development field and their interest in successful drug development and in finding scientific truth is clear cut. While the course involves many leading academics and industry physicians who have considerable knowledge, each year the Symposium demonstrates that the FDA participants who are senior at the agency consistently demonstrate a broad knowledge of the field of drug development. |
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Clearly, the FDA can facilitate drug development further than what is currently being done. There are times that the delays are needless and the debate is not helpful, but the drug lag behind Europe, which so severely crippled therapeutics in the 50s, 60s, and the 70s, no longer exists as a problem. However, excessive drug regulation is not the goal. Rather more expeditious, less costly development in the information age is a goal that needs to be set by the FDA. A case-by-case review is no longer needed. To have each data point separately chronicled and meticulously reviewed for efficacy and toxicity by a junior reviewer is an immense waste of time. Having the primary reviewer recreate the NDA piece by piece and then producing their own summary is a laborious process that obviously can take a year or more. The NDA is put together by hundreds of individuals highly trained in the pharmaceutical industry and having one or two people go through this on a line-by-line basis and check every data point and reanalyze the presentations is going to be a most arduous time-consuming process. Quality assurance techniques are in place to ensure accuracy and integrity of a NDA data base. The FDA could make use of these techniques and clearly the FDA will need to strengthen procedures by the century's end and apply sophisticated computer techniques to make the analyses as expeditious as possible. To keep up with the information age, the FDA will be one of the links in the drug development process that is most stressed by forthcoming change. User fees and more FDA revenues are not the answer, and placing the cost of submission beyond the capacity of small start-up companies is ill advised. Using these funds for more and more reviewers to expand the laborious almost hand approach to data review is fallacious. Many of these programs are not objected to by the giants of industry and are in fact encouraged because they once again appease those who want to speed |
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