Quality Systems

Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

Heparin contamination casts a shadow on regulatory oversight of product quality.

Brief pharmaceutical news items for April 2008.

Manufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.

US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics.

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

The US Pharmacopeial Convention announced a revised glycerin monograph in the United States Pharmacopeia.

As part of ongoing efforts to improve the quality of imported drug products, the US Food and Drug Administration is setting up shop in China.

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

The US Senate passed an amendment to the fiscal year 2009 budget bill that will increase the amount allotted to FDA by $71 million, bringing the agency's total FY 2009 budget increase to $375 million.

Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website.

The US Pharmacopeial Convention (USP) signed a Memorandum of Understanding (MOU) with the Chinese Pharmacopoeia Commission (ChP) designed to strengthen the quality of medicine and foods in the United States and China.

The US House of Representatives Committee on Homeland Security approved legislation last week that mandates inherently safer technologies (IST) as part of chemical-site security standards, a move that was opposed by the Synthetic Organic Chemical Manufacturers Association.

Concerns over contaminated heparin product worsened as US officials announced dialysis patients in Germany have fallen ill after using a different brand of the blood thinner than was already being recalled.

Also, PDL BioPharma will no longer pursue sale of the company, executives resign from Topigen Pharmaceuticals, more...

Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research.

Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

With another potential "made-in-China" crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration.

Draft federal legislation that would require high-risk chemical facilities to use inherently safer technology for reducing their risk may present potential problems for custom and batch manufacturers supplying the pharmaceutical industry.

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

Quality-by-design submissions may reduce supplements and improve change management.

A. Nair discusses patent disputes in India.

If not properly monitored, filters and plastic bags can keep back more than they should.