The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency's jurisdiction.

Also, BASi opens European office in Warwickshire, UK; Acusphere's Howard Bernstein Resigns; More...

US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration.

Rep. John Dingell (D-MI) plans to introduce the Food and Drug Globalization Act discussion draft as a bill early next year.

Novo Nordisk will invest nearly $400 million to build a new insulin plant in Tianjin, China.

Also, Patheon opens new European headquarters, Cynvec appoints Frank D. Stonebanks president and CEO, more...

The Steering Committee and Expert Working Groups of the International Conference on Harmonization are meeting this week in Brussels to discuss current harmonization efforts.

PAT may reduce costs by helping companies control process variability, improve yields, reduce waste, and produce high-quality therapies consistently. Companies that have not yet embraced PAT may find its potential to reduce expenses a compelling argument in its favor during this time of financial difficulty.

Until recently, automated inspection of solid-dose pharmaceuticals was crude, expensive, slow, and difficult to change over. But technological advances have ushered in a new class of vision-inspection systems that is more effective and more commercially viable than older systems.

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use recommended that the status of GlaxoSmithKline's anti-obesity drug "Alli" (orlistat) be switched from prescription-only to nonprescription.

Also, Sartorius Stedim Biotech GmbH to acquire Wave Biotech; AstraZeneca's John Patterson to retire; more...

Arguments in the Supreme Court case Wyeth v. Levine have concluded, leaving both sides to wait possibly until early 2009 for a decision in a preemption case involving the misadministration of Wyeth's "Phenergan."

The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company's "Bayer Women?s Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" over-the-counter (OTC) products.

The US Food and Drug Administration has issued a final rule requiring the addition of a statement and toll-free number to the labeling of certain human drug products.

Near-stagnant growth for the US pharmaceutical market, the rising influence of emerging markets and specialty products, and increased penetration of generic drugs are major issues for the global pharmaceutical market.

Uncertain economic times crimp the financing flow into the US biotechnology industry.

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.

A well-balanced guide to industrial bioseparations provides valuable information.

Brief pharmaceutical news items for November 2008.

Data capture needs to be fast and reliable...so which automatic identification technology is best?

Attendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.

With government support, China's pharmaceutical equipment sector is trekking ahead despite challenges regarding the country's overall perceived product quality.

The Indian government may soon monopolize its pharmaceutical industry to cut costs and improve healthcare, but the move is sounding off alarm bells with the companies whose drug products are under review.

The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Production problems come in all shapes, sizes, and ... species.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.