United States. Food and Drug Administration

Drugs

FDA Raises Second Non-Compliance Concern with Abbott Laboratories

The US Food and Drug Administration (FDA) has cast a shadow over Abbott Laboratories by raising its second non-compliance concern in a year, this time regarding quality control at the company's Chicago plant that manufactures kits for medical diagnostic tests. The kits are used in testing fluids for

Pharmaceutical industry

FDA Advisory Committee to Review New Cancer Treatments

A panel of expert advisors at the U.S. Food and Drug Administration (FDA) is set to review several new cancer treatments, including a possible new use for Taxol, a leading cancer drug that generated $1.2 billion in sales for Bristol-Myers Squibb Co. in 1998. The committee will consider

Pharmaceutical industry

Novartis Receives Approvable Letter for Trileptal from FDA

Novartis Pharmaceuticals Corporation announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for Trileptal(R) (oxcarbazepine) tablets, a new therapy for the treatment of partial seizures in adults and children. The approvable letter represents the final step before a product receives FDA clearance

Drugs

FDA Inspections Reveal Computer System Deficiencies

Pharmaceutical companies are facing increasing scrutiny from the FDA regarding their computer systems, as inspections reveal a trend of deficiencies that may lead to regulatory issues. Industry experts warn that a lack of system requirements, inadequate validation documentation, and inadequate protocols have become common findings during FDA audits. The consequences

Pharmaceutical industry

Sterilization Validation Failures Exposed in Recent FDA Letters

The US Food and Drug Administration (FDA) issued warning letters to three pharmaceutical companies, Gensia Sicor, Medi-Physics, and TMED, citing failures in sterilization validation. The letters highlight critical issues in process validation, equipment sanitization, and quality control procedures. The inspection and subsequent letters demonstrate the FDA's focus on

Drugs

Celebrex Receives Priority Review for Familial Adenomatous Polyposis Indication

Familial adenomatous polyposis (FAP) is a rare genetic disorder characterized by the development of numerous adenomatous polyps in the colon and rectum, often associated with elevated COX-2 expression. These polyps are precursors to colorectal cancer, and left untreated, nearly all patients develop the disease by age 40-50. G.D. Searle

Pharmaceutical industry

Coulter Pharmaceutical and SmithKline Beecham Announce FDA Request for Modifications to Bexxar Marketing Application

Coulter Pharmaceutical, a biotechnology company specializing in therapeutic antibodies and targeted oncologics, has partnered with SmithKline Beecham, one of the world's leading healthcare companies, to develop and market Bexxar, a novel monoclonal antibody conjugated to a radioisotope. The U.S. Food and Drug Administration (FDA) has requested modifications

Drugs

FDA Regulation of Supplements and Herbal Remedies: A Call to Action

The House of Delegates has reaffirmed its interest in FDA regulation of supplements and herbal remedies in response to continued physician concern about their potential risks to patients. A growing number of patients are experimenting with these products, some of which offer true therapeutic benefits while others harm patients. The

Drugs

STC Technologies Receives FDA Clearance for Histofreezer(R) Portable Cyrosurgical System

STC Technologies, Inc. (STC) has announced that it has received clearance from the Food & Drug Administration (FDA) to market its Histofreezer(R) Portable Cyrosurgical System for the treatment of actinic keratoses and lentigo, common premalignant skin tumors and age spots, respectively. This clearance marks a significant milestone for STC,

Drugs

FDA Warns of Computer Software Vulnerabilities in Laboratories

Federal regulators are sounding the alarm about potential vulnerabilities in computer software used in laboratories, with FDA officials expressing concerns about systems that cannot detect or prevent data tampering. Pharmaceutical companies are being warned to ensure that their computer systems can detect and track changes to laboratory records, a crucial

Drugs

American Home Products Corporation Receives FDA Approval for Protonix

American Home Products Corporation (AHP), a major research-based pharmaceutical company, has taken a significant step in the development of Protonix, a proton pump inhibitor (PPI) for the treatment of gastrointestinal reflux disease. Having received a "approvable" designation from the Food and Drug Administration (FDA), AHP's Wyeth-Ayerst

Pharmaceutical industry

FDA to Increase Inspections of Biologics Makers

The US Food and Drug Administration (FDA) is stepping up its inspections of makers of licensed biologics, including biotech drugs, and pharmaceutical company laboratories in the coming year. According to Dr. Rebecca Devine, associate director for policy at the Center for Biologics, the agency's "Team Biologics"