Quality Systems

Customers complaining lead to some serious explaining.

Brief pharmaceutical news items for June 2008.

The author provides an overview of key regulatory issues facing companies seeking to market their biopharmaceutical agents globally.

Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting.

With rising drug deveopment costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entities in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards.

Letting the public inside the drug development process may increase their faith in what we do.

The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.

The good, the bad, and the ugly about direct-to-consumer advertising.

The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

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.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

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...

Once again, the US Food and Drug Administration is under fire for not doing its job. This time the issue is direct-to-consumer (DTC) advertising.

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.

Congressional hearings were held last week on the Food and Drug Administration Globalization Act discussion draft.

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

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.

Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.

With counterfeiting on the rise and Europeans worried their backyard is becoming a base for such illegal activity, legislators have proposed a series of solutions that span the continent and abroad.

The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.

The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.

Regulators face demands to improve postmarket surveillance and meet review deadlines.

INTERPHEX 2008 offered visitors novel experiences and many stimulating sessions.

WFI system deficiencies and damp tax records cause problems for two plants

The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.

US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, "Restoring FDA's Ability to Keep America's Families Safe."