The plans include use of non-FDA contractors to review drugs, adoption of rules that accelerate the approval process -- including greater use of surrogate markers in clinical trials -- harmonizing drug approvals with foreign countries, and management improvements at the FDA...The development of common procedures would reduce the requirement to duplicate clinical trials in different countries and would "speed the approval of drugs worldwide," said HHS Director Louis Sullivan

Sponsors will be allowed to negotiate with the FDA to obtain certain data from post-marketing studies now required in Phase III clinical trials...U.S. Recognition of Foreign Approvals The United States will develop with modern industrialized countries common standards for clinical trials, submission of drug approval applications, requirements for animal testing, good manufacturing practices, plant inspections and so on

8 (Phase III) Major Reasons for Savings: Fewer clinical trials (accelerated

Members called for shorter clinical trials to speed the development of a vaccine

Taxol has shown promise in Phase III clinical trials for recurrent ovarian cancer and is also in Phase II trials for breast cancer

Cellular has treated more than 200 rodents over the past year and a half, said Dr. Seth Rudnick, the company's president and chief executive and plans to begin clinical trials by the end of 1992

Tarrytown, N.Y.-based Regeneron plans to file an investigational new drug application by mid-1992 to begin clinical trials of CNTF

Brocades, a Yamanouchi Group company, will cover the costs of clinical trials, regulatory approvals, manufacturing development and scale-up, and marketing and distribution, subject to milestone performance by Lidak

30, which the company attributed to aggressive investment in marketing in Europe and the United States, and increased research and development costs associated with its four products in clinical trials...Centocor last week said it plans to begin Phase III clinical trials of Centara, its anti-CD4 compound to treat rheumatoid arthritis, sometime in 1992. (c) 1997 American Health Consultants

The funds, along with $5.5 million in cash already held by the Fort Washington, Pa., company, will be used to complete clinical trials and support commercialization of Therafectin and to continue clinical development of GW-80126

and a Chiron Corp./Ciba-Geigy collaboration have IGF without binding protein in clinical trials, said Pharriss

said Wednesday that it has received Food and Drug Administration approval to expand clinical trials of Dermagraft, its living dermal replacement product, from 12 to 24 burn centers

said Tuesday that it is beginning Phase I clinical trials of soluble interleukin-1 receptor to inhibit allergic reactions to skin allergens...Later this year, Immunex plans clinical trials of IL-1 receptor to treat rheumatoid arthritis

The San Diego-based company in August filed to begin Phase I/II clinical trials of its antisense compound to treat chronic myelogenous leukemia

The company also said it plans to expand clinical trials of the drug in humans

The subsidiary will market Genzyme products directly in Europe, as well as move products through European clinical trials and regulatory approval

has received Food and Drug Administration approval to begin a Phase I clinical trial of its rationally designed drug for topical treatment of psoriasis, the company announced on Monday

The company expects the drug to enter Phase II/III clinical trials in the first half of 1992

said Friday that it has begun Phase I clinical trials of BioTropin recombinant human growth hormone in patients with HIV