FDA Resources

Besides 21 CFR - Part 11, the FDA has many other documents that govern your work as a SAS programmer in the pharmaceutical industry. Here are some of them  

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FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Furthermore, significant industry and FDA resources are spent debating issues related to acceptable variability, need for additional in-process testing and how specification acceptance limits should be established. Often these debates are focused on acceptance limits or the statistical aspects. In these debates a proportionate focus on the underlying manufacturing science is often missing. For example ... 

FDA resources are used most effectively and efficiently to address the most significant health risks. 

With FDA resources ever under triage, the Agency is intensely seeking ways to improve the ANDA review process. There are three strategies—two official, one sub rosa—in process. 

While these techniques should provide some sort term relief they do not address the fundamental problems of relative decreasing of FDA resources even as Agency responsibilities are increasing. Until this fundamental problem is addressed, the review process for ANDAs—and for NDAs—will grow increasingly lengthy, inefficient, and frustrating. 

To focus FDA resources on areas of manufacturing considered to pose the greatest risk. 

As this strategy evolves over time, it can be expected that the FDA will devote more of its resources to the oversight of high-risk operations and emerging technologies, with consequently less attention on low-risk activities. 

The trial was run, and FDA approval, on the basis of the results, was obtained. The drug is currently commercially successful. Were it not for the new team member who commissioned this work, this trial would have failed— at a cost of 50 million and the loss of two years of revenue. Moreover, other efficiencies (fewer patients, faster recruiting, better understanding of patient and market stratification) would not have been realized. The cost (in time and resources) for modeling projects should be balanced by the benefits of increased likelihood of success (for a drug that will be successful) and of possibly avoiding a trial for a compound that cannot succeed. 

At a minimum, the method will be tested in one FDA laboratory and two contract laboratories selected by the sponsor. If the method is for a new animal drug in tissue regulated by the United States Department of Agriculture (USDA) as part of the meat inspection program, a Food Safety and Inspection Service (FSIS)/USDA laboratory will be included if sufficient resources are available. The method trial will be conducted using control and incurred target tissues that are supplied by the sponsor. The sponsor may, on request, supply new or unusual reagents or standards. 

Sources of information other than FDA pregnancy labeling exist that may provide more useful information to the clinician (Table 44-2). It still should be noted that these resources share the limitation of deriving recommendations largely from data from case reports and surveillance data. Consequently, clinicians often are forced to advise patients based on limited evidence. 

Purpose The mission of the National Institute of Neurological Disorders and Stroke (NINDS) Office of Translational Research is to facilitate the pre-clinical discovery and development of new therapeutic interventions for neurological disorders. The Office supports pre-clinical projects from the discovery of candidate therapeutics through IND and Investigational Device Exemption (IDE) applications to the FDA. This is accomplished through both access to NINDS contract resources and direct funding mechanisms. 

Therapeutic considerations associated with pregnancy and lactation encompass many complex issues that affect both the mother and her child, from planning for pregnancy through lactation. Resources on the use of drugs in pregnancy and lactation include the FDA categorization system, the primary literature, textbooks, and computerized databases (e.g., the Canadian database, http //vmvw.motherisk.org). 

Industry Resources Business Opportunities FDA/EPA/OSHA Reimbursement/ Payment Global Year 2000 Government Relations Public Relations Small Company Diagnostics... 

Sponsor 1) A person who initiates and supports, by provision of financial or other resources, a (nonclinical laboratory) study 2) a person who submits a (nonclinical laboratory) study to the EPA (FDA) in support of an application for a research or marketing permit or 3) a testing facility, if it both initiates and actually conducts the study. 

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