IND AUTOMATED MANAGEMENT INFORMATION SYSTEM IS AMONG FDA FUTURE GOALS: FDA ISSUES "PROGRESS REPORT" FOR 1984-1988; REPORT HIGHLIGHTS "REVITALIZATION"
Refinement of FDA's automated information system to monitor IND submissions is among the agency future goals in the drug review area, according to a just-released "Progress Report of the Food and Drug Administration 1984-1988." In a summary of the agency's "future goals," the FDA report notes that the agency plans to "improve its automated management information for all INDs." FDA said it will "look for other automated systems, including knowledge-based decision support systems and other artificial intelligence support tools of modern computer technology that can be of assistance both in the short term and in the long term." Also in the area of computer technology applications for the agency's drug review function, the report lists continued experimentation with electronic NDA's among FDA's future goals. The agency's aim, the report notes, is "that NDA data can be not only received electronically, but also tabulated and analyzed with electronic support." The progress report outlines FDA's public health "accomplishments" from 1984 to the present -- essentially, during Commissioner Young's tenure as head of the agency. The internal FDA report lauds the "revitalization" of FDA during the past four years, crediting the Administration's Action Plan, now in its third stage. Reflecting the political year, the report also praises the current Administration. "With the strong support of Secretaries Bowen and Heckler, the FDA has appreciably increased its capability to promote public health during the past four years," the report begins. "FDA's program results over the past four years reflect strong commitment of the Administration in fulfilling its public health mission," the report states. "These accomplishments are summarized in the report [and] are particularly noteworthy because they came at a time in which FDA was faced with dramatic increases in workload, diminished resources, rapidly advancing technologies, and an unprecedented number of public health emergencies." Other future goals listed in the report in the area of new drug review include: * continuation of recruitment and resource reallocation; * expanded use of Phase IV studies and the "search for alternative endpoints for clinical trials"; * "vigorous" implementation of the Treatment IND regulation and education of health professionals and the public about the reg; * involvement of universities "in both training and personnel and the evaluation process," and * "most significantly," continuation of research in the drug development process to identify and remove barriers to innovation." Among the program results in the drug review area in the past four years, the report cites the designation of AIDS "as FDA's number one priority"; "improving the timeliness, effectiveness, and efficiency of the new drug review process"; development of the Treatment IND process; and a reduction in "the time in which new chemical entities move from early laboratory work to FDA approval by an average of two years less time than in the past from 10 years in the past to eight years today."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth