About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

USP membership meeting prepared the standards-setting body to meet modern challenges.

A timely new book explains techniques for conformational analysis.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Too much or too little control can actually lead to the same result.

Despite being a historically strong performer in the pharmaceutical arena, Germany is now underperforming compared with the growth of other European markets.

Have you ever come across a new technology, process or problem in your profession and wanted to tell others or learn more about it?

Despite its potential, why is personalised medicine still not widely used in healthcare?

A collaboration involving GlaxoSmithKline and two British universities is looking to create faster acting medicines with a technology that prints APIs onto a tablet?s surface.

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines?60% higher than the agency's forecast.

FDA and NIH Launch New Safety Reporting Website; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Late last week, the US food and Drug Administration's Transparency Task Force published a series of proposals on public disclosure policies.

Signaling its interest to strengthen its presence in emerging markets, Abbott (Abbott Park, IL) has agreed to acquire Piramal Healthcare Ltd.'s (Mumbai, India) Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion.

Pfizer has begun implementing the first phase of its Plant Network Strategy, which will result in the loss of approximately 6000 jobs over the next several years.

More acquisitions are expected as the patent cliff pushes the pharma industry into a critical phase, with many executives believing that the industry will be unable to innovate sufficiently from within to replace blockbuster drugs.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

FDA Clears Infant Rotavirus Vaccine

The US Food and Drug Administration launched a program last week designed to "educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful."

Pfizer (New York) announced this week plans to reconfigure its global manufacturing network as part of its integration following its $68-billion acquisition of Wyeth (Madison, NJ) in 2009.

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Sundlof Resigns as FDA's Head of Food Safety; and More

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The European Ombudsman has recommended that the European Medicines Agency review its refusal to grant public access to reports on adverse drug reactions.