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The drug development process occurs within the structure defined by the Food and Drug Administration. From initial clinical testing in Phase I to later Phase II and III clinical trials, the FDA has considerable influence and control while at the same time exercises a minimal degree of interference that is often surprising. Unlike European agencies, for example, the scientific levels of the Food and Drug Administration are most accessible at all stages of development from pre-IND, pre-Phase II or pre-NDA meetings, and the FDA can provide meaningful guidance in a drug development program. Yes, they will be the judges of the data presented and the keepers of the regulations, but I believe their assistance comes more from experience in the drug development process. The scientific division chiefs and other senior individuals at FDA see a tremendous number of clinical trials, have often encountered clinical development problems, and can, without the disclosure of confidential information, provide considerable assistance to those involved in drug development. While an individual in a company may be involved in four or five compounds over a career in terms of major development programs, the FDA senior people may see that in a week and from many different perspectives. Clearly, the FDA is the nexus of pharmaceutical development information and training that unfortunately has not been tapped into as effectively as it should be. |
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To consult the FDA while involved in drug development is a most advisable approach. The FDA and industry working together on a product will often evolve a development program that is more effective and more efficient in time and resources. Too many may take FDA's advice as dictum. There is what could be termed the shadow FDA. Those regulatory advisors in industry telling us what the FDA requires and wants, all too often offer distorted advice and impede effective drug development. The FDA should be looked upon as an important resource, with whom those pivotally involved in drug development in industry should communicate directly. Regulatory advisors, consultants, past regulators, facilitators, and legal advisors all have their place but should not be interposed between those individuals at companies who are critical links in drug development. No advice should be binding, but needs to be discussed and reasonable approaches taken. The individuals at the FDA are not omniscient. A development plan may not work out and may need substantial modification. Failure to realize this and blindly going forth after an FDA conference can lead to failure. Coming back to the FDA and saying, But this is what we were instructed to do, is foolish and in a sense undercuts the free and open exchange of ideas between the regulators and the developers. Advice is what is given, and reproach later because of changing circumstances, developments in the field, or just lack of efficacy of a compound, cannot be blamed |
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