Quality Systems

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a condition that accounts for more than 80% of the estimated 85000 new cases of kidney cancer diagnosed in Europe every year.

Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.

Congress Focuses on FDA Inspections of Foreign Drug Facilities; Medical Students Oppose Big Pharma's Influence on Campus; FDA Revises Postmarketing Reporting Requirements

There are at least two major factors that will shape the manufacturing industry as a whole. Daniel Ruppar, Industry Manager (North America) for the Pharmaceuticals and Biotechnology Division of Frost & Sullivan predicts that, due to continued globalization, we can expect to see "growth centers for the industry move to emerging market sectors."

To keep up with applications, FDA promotes new testing and administrative methods.

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.

The "why" things are done in this industry is just as important as the "what"and "how."

"May you live in interesting times," goes the allegedly ancient Chinese curse. Well, these have been "interesting times" indeed for those working in the pharmaceutical industry.

Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.

The US Food and Drug Administration has issued Ben Venue Laboratories a Warning Letter resulting from CGMP deviations found during an inspection of the company?s ?Propofol? injectable emulsion manufacturing facility earlier this year.

The US Government Accountability Office issued findings that are largely critical of the US Food and Drug Administration in managing its inspections of foreign drug-manufacturing facilities.

The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States.

The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.

Looking to resolve litigation over Vioxx (rofecoxib), Merck & Co reached an agreement to settle the vast majority of Vioxx claims for $4.85 billion.

The current system for regulating imported drugs is putting consumers' health and safety at risk.

Wyeth Consumer Healthcare launched a voluntary recall and replacement program for US retail outlets that sell several ?Robitussin? and ?Children?s Dimetapp Cold and Chest Congestion? products.

US Food and Drug Administration Commissioner Andrew C. von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology systems.

The US Food and Drug Administration’s effectiveness in regulating the manufacture of pharmaceutical products and active pharmaceutical ingredients at foreign facilities was questioned at a Congressional hearing last week. Congress, industry, and government officials weighed in on the issue.

Information technology is the glue that should unify a company while ironically, it enables further fragmentation. Experts talk about the successes and challenges for IT in helping a company function efficiently.

The US Food and Drug Administration launched a new program on Oct. 4 to increase the number and variety of generic drugs available to the public, beginning in fiscal year 2008. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the agency "modernize and streamline the generic drug approval process," according to FDA.

In this study, fault tree analysis applied to a water pretreatment and purification installation exposed cause-and-effect complex interrelations in possible fault events.

Representatives from 17 nations sit down to decide upon standards-setting initiatives.

News and Views

Thin are the lines that separate stability, statistics, and chaos.