Drugs
Philip Morris, the nation's largest cigarette maker, has undergone a significant shift in its stance on tobacco regulation. After decades of denials, the company has publicly acknowledged that smoking is addictive and causes cancer and other fatal diseases. This move follows a pattern of growing public pressure and
Pharmaceutical industry
Cell Pathways, Inc. (CPI) has received a significant update from the U.S. Food and Drug Administration (FDA) regarding the review of their New Drug Application (NDA) for Aptosyn(TM) (exisulind) to treat Familial Adenomatous Polyposis (FAP). The FDA plans to evaluate the NDA without requiring input from its Oncologic
Pharmaceutical industry
A new drug, VANLEV, is being fast-tracked by the US FDA for approval to treat high blood pressure, a condition that affects over 50 million Americans. This novel cardiovascular compound, discovered by Bristol-Myers Squibb researchers, targets a new class of enzymes that regulate blood pressure. The FDA has indicated that
Pharmaceutical industry
PharmaNetics, a Raleigh-based holding company, has submitted an application for Humanitarian Device Exemption (HDE) approval to the FDA for its Ecarin Clotting Time (ECT) test card. This innovative device is designed to monitor the anticoagulant effect of Refludan, a thrombin inhibitor used during cardiopulmonary bypass surgery for patients with heparin-induced
Drugs
Boston Life Sciences, Inc. is set to meet with the FDA in the first quarter of 2000 to discuss its application for the approval of Therafectin, a drug for the treatment of rheumatoid arthritis. The company submitted a letter to the FDA in response to the agency's request
Drugs
Ligand Pharmaceuticals Incorporated, a pioneering biopharmaceutical company, has achieved a significant milestone with the approval of Targretin capsules for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy. This approval marks a major breakthrough in the treatment
Pharmaceutical industry
As the internet continues to revolutionize the way we shop and access services, concerns have risen about the regulation of online prescription drug sales. In an effort to prevent a pharmaceuticals black market from developing in cyberspace, the Food and Drug Administration (FDA) is set to be put in charge
Pharmaceutical industry
ILEX Oncology and its partner, Millennium Pharmaceuticals, have submitted a Biologics License Application to the United States Food and Drug Administration (FDA) for CAMPATH, an investigational humanized monoclonal antibody. This application is part of the companies' efforts to secure marketing approval for CAMPATH, which has been granted "fast
Pharmaceutical industry
The Food and Drug Administration's guidance on the use of computerized systems in clinical trials emphasizes the importance of validating the process, verifying the design, and qualifying the operation to ensure the accuracy and reliability of the data. This approach is essential in the development of software quality
Drugs
SAP's reputation for lengthy implementation and validation processes is being challenged by a firm in suburban Philadelphia that has created preconfigured systems to accelerate the process. The pharmaceutical solution architect at SAP America, Dr. Joseph Cardarelli, notes that the preconfigured systems integrate the best business practices in the
Drugs
The Strategic Research Institute is hosting a comprehensive conference on food labeling and health-related claims, scheduled for January 28-29, 2000, at the Wyndham Washington D.C. The event will feature insightful keynote presentations, mini-workshops, and panel discussions led by renowned experts in the field. Keynote speakers include Peter Barton Hutt,
Drugs
The FDA has identified several key areas of concern when inspecting process validation in the biotechnology industry. According to Gregory Bobrowicz, a former FDA investigator and compliance officer, four primary red flags include partial lack of validation, inadequate failure investigation, uncontrolled variation within specs, and problems with documentation. To address
