Pharmaceutical Technology Editors

In a white paper published today, the US Food and Drug Administration described its Sentinel Initiative to create an electronic safety system that tracks drug performance.

Cambridge Consultants is developing a low-cost portable instrument to test respiratory drug-delivery devices.

The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration's drug and medical device regulation bar state liability claims.

Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...

PharmTech's monthly newsletter, reviews the Editor's Picks for the May 2008 edition: Watson-Marlow Flexicon and HealthStar

Controlling modular, self-contained process skids (known as plug-and-play components) with an automation system can increase a pharmaceutical manufacturing facility?s flexibility.

Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.

Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...

Researchers at the University of Southern California's Information Sciences Institute (ISI) demonstrated a way to manufacture miniscule containers called voxels that could potentially deliver precise microdoses or even nanodoses of drugs.

To establish user fees for the 2009 fiscal year, the US Food and Drug Administration is asking pharmaceutical manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16, 2008.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.

Merck and Company?s West Point, Pennsylvania facility received a Warning Letter from the US Food and Drug Administration.

Brief pharmaceutical news items for May 2008.

Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

MannKind suspended discussions with potential partners for the commercialization of its "Technosphere Insulin" product.

This issue of Equipment & Processing Report features products from Leistritz and Millrock Technology

Dave Drew, group pharmaceutical director of Matcon (Moreton-in-Marsh, UK), says that lean production is essential for drugmakers to survive in the current environment.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, Jubilant Organosys to acquire DRAXIS Health, PPD's Paul Covington to retire, more...

Combining atomic force microscopy and infrared spectroscopy, scientists at the University of Illinois have demonstrated a method for simultaneous structural and chemical characterization of samples at the femtogram (10-15g) level.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.

One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.