The U fare and Drug Administration...

The U fare and Drug Administration (FDA) not long ago announced the completion of the first phase of objectives of its initiative to modernize the agency's regulation of pharmaceutical manufacturing and outcome quality. Some of the objectives that have been achieved include the following: clarifying the latitude of the FDA's electronic submission and record-keeping requirements; facilitating continuous improvement and innovation in manufacturing by means of allowing manufacturers to make certain archetypes of changes in their processe without previous FDA approval; launching a program to identify and address inconsistencies across program areas; focusing FDA resources upon inspections that will have the greatest public health impact; and enhancing the agency's expertise in pharmaceutical technologies by means of hiring additional experts and collaborating with academic assemblages and external experts. Long-term goals of the initiative include the following: ensuring that state-of-the-art pharmaceutical science is used in the regulatory review and inspection policies; encouraging the adoption of modern technologic advances in high-quality and efficient manufacturing according to the pharmaceutical industry; strengthening public health protection through implementing risk-based approaches; and enhancing the consistency and coordination of the FDA's mix with drugs quality oversight activities. The initiative, "Pharmaceutical passing from hand to hand Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk Based Approach," was designed to evaluate and improve the agency's approach to reviews and inspections related to the manufacturing of human and animal medicines and biologics. This initiative is part of the Department of Health and Human Services (HHS) Secretary Tommy G Thompson's broader efforts to improve and streamline the regulatory proces to improve Americans' access to quality health care and services.

COPYRIGHT 2003 American Academy of Family Physicians

COPYRIGHT 2003 Gale Group