21st Century Essential Guide to Cellular and Gene Therapy, Stem Cells, and Cloning - Coverage of Documents and References from the Food and Drug Administration (CD-ROM)

This electronic book on CD-ROM provides coverage of cellular and gene therapy, along with a collection of documents, publications, and reference sources on other aspects of the Food and Drug Administration (FDA). The Center for Biologics Evaluation and Research (CBER) regulates human gene therapy products - products that introduce genetic material into the body to replace faulty or missing genetic material, thus treating or curing a disease or abnormal medical condition. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. FDA has not yet approved any human gene therapy product for sale. However, the amount of gene-related research and development occurring in the United States continues to grow at a fast rate and FDA is actively involved in overseeing this activity. FDA has received many requests from medical researchers and manufacturers to study gene therapy and to develop gene therapy products. Such research could lead to gene-based treatments for cancer, cystic fibrosis, heart disease, hemophilia, wounds, infectious diseases such as AIDS, and graft-versus-host disease. FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency's specific responsibilities include: Biologics - product and manufacturing establishment licensing; safety of the nation's blood supply; research to establish product standards and develop improved testing methods; Cosmetics - safety; labeling; drugs; product approvals; OTC and prescription drug labeling; drug manufacturing standards; Foods - labeling; safety of all food products (except meat and poultry); bottled water; Medical Devices; premarket approval of new devices; manufacturing and performance standards; tracking reports of device malfunctioning and serious adverse reactions; Radiation-Emitting Electronic Products - radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities; Veterinary Products - livestock feeds; pet foods; veterinary drugs and devices.