Pharmaceutical industry
Aquitaine Pharm International, a small-volume parenteral (SVP) manufacturer based in Idron, France, has received FDA approval to ship SVPs to the U.S. despite a 483 that highlights the exacting standards of FDA inspectors for environmental monitoring, validation, investigation records, and master batch records. This is the company's
Drugs
Watson Laboratories, a generic drug maker based in Corona, California, faced a critical inspection in December 1998, which resulted in a recommendation for approval. However, a warning letter was issued in January 1999, demonstrating the complexities of the regulatory environment in the pharmaceutical industry. The inspection, conducted by investigators Virgilio
Drugs
FDA inspections of Alpha Therapeutic's plasma collection facilities in Seattle, WA, reveal ongoing concerns about donor screening and plasma fractionation, echoing previous issues with contamination and inadequate SOPs. The agency's letter in July 1998 criticizes Alpha's handling of unsuitable units and lack of documentation,
Drugs
Pharmaceutical companies must take regular water sampling and validation of water systems seriously, as emphasized by FDA experts at the 1998 West Coast Chapter meeting of the Parenteral Drug Association (PDA). This emphasis comes as part of a broader effort to standardize and clarify regulations surrounding water control, both for
Drugs
The FDA inspection of Coulter's retrovirology facility in Hialeah, Florida, uncovered several deficiencies, including issues with validation records and product validations. The audit, conducted from April to June 1997, revealed a lack of justification for not using production runs to demonstrate reproducibility and assess variability over time. Additionally,
Pharmaceutical industry
Regulatory inspections at the FDA have raised concerns about computer validation, with the agency's Small Business Representative, Marie Falcone, pointing to a low rate of citations for this issue in fiscal 1998. Despite the FDA's educational efforts and industry's good job, Falcone believes that
Pharmaceutical industry
Warner-Lambert, the manufacturer of Rezulin, is facing significant challenges in maintaining its market share in the diabetes treatment market. Recently, a US Food & Drug Administration advisory panel imposed strict conditions on Rezulin's use, deeming it safe only when used in combination with other treatments. This decision comes
Pharmaceutical industry
The approval by the US Food and Drug Administration (FDA) for the sale of the anti-influenza drug Relenza was seen as a major boost for Australia's biotech industry, with Biota Holdings Limited, its Melbourne-based developer, expected to reap significant profits. However, the FDA panel's 14-3 rejection
Pharmaceutical industry
Biota Holdings' market value more than halved last week after a US FDA panel voted against recommending the approval of its flu cure, Relenza, in the lucrative US market. The company's managing director, Dr Hugh Niall, admitted that a speedy resolution to the impasse was unlikely, but
Drugs
The Food and Drug Administration (FDA) has approved Monsanto's Celebrex, a revolutionary type of arthritis medication, as the first "cox-2" inhibitor to hit the market. However, in a blow to Monsanto, the FDA declared that there is no proof that Celebrex is safer for patients'
Pharmaceutical industry
The US Food and Drug Administration (FDA) will adjust its inspection priorities in 1999, with a significant decrease in the number of Bioresearch Monitoring (BiMo) and foreign inspections. The Office of Regulatory Affairs (ORA) has devised a field inspection "work plan" that outlines the projected number of inspections
Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved Celebrex, a new type of painkiller designed to alleviate arthritis pain while minimizing stomach-plaguing side effects. However, the agency cast doubt on the drug's purported safety benefits, stating that there is insufficient evidence to prove it is easier on
