Quality by Design

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd, and ProStraken Group plc have been accused of breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.

Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced earlier this week that John J. Castellani will replace Billy Tauzin as President and Chief Executive Officer.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

President Obama signed into law major healthcare reform following the passage of the bill by the House of Representatives.

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

References for the article published in the February issue of Pharmaceutical Technology Europe.

The US Food and Drug Administration released a warning to the public on Dec. 29, 2009 about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The European Public Health Alliance published its comments about the Falsified Medicines Directive currently under debate by the European Parliament and Council.

The authors discuss a study that demonstrates the use of polyethylene oxide mixtures to investigate the effect of polymer viscosity on formulation robustness.

On Sunday, Nov. 8, 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its disappointment with the US House of Representatives's healthcare-reform bill.

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD -Aegis Whitepaper

Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.

FDA leaders explain the purpose and plan for ICH's three quality guidelines.