Manufacturing

FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

Industry associations will soon provide new recommendations about extractables and leachables.

This month's BIO Convention will encourage needed conversations.

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues.

India's drug pricing authority increased the retail costs of certain domestically manufactured drugs, but not those of imported drug products. Pharma is asking why.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.

Takeda Pharmaceutical has agreed to acquire Nycomed, a Swiss pharmaceutical company for $13.5 billion, excluding Nycomed's US dermatology business. The deal is intended to increase Takeda's presence in European and emerging markets.

Global spending on medicines will total almost $1.1 trillion by 2015, according to an IMS Institute for Healthcare Informatics study.

Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo.

Johnson & Johnson subsidiary Janssen-Cilag International reported that the company is working with regulatory authorities in five countries to address trace amounts of 2,4,6- tribromoanisole identified in five batches of the HIV/AIDS medicine Prezista.

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.

Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.

How do you assign a minimum sample weight for a US Pharmacopeia <41> balance application when the tested repeatability gives a standard deviation of zero?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2011 edition from David Round Company and Globe Medical Tech.

Filling active ingredients directly into capsules is probably the quickest option for entering clinical trials. This case study compares manual and automated methods of capsule filling.

The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.

In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

An upcoming conference by the Drug, Chemical and Associated Technologies Association (DCAT) will focus on innovative practices and strategies for optimizing sourcing, procurement, and the management of the pharmaceutical supply chain.

Extending a drug product's shelf life while maintaining its strength, quality and purity is a challenge for pharma companies.

There are a number of points to consider where secondary packaging is concerned.

Legislation has prompted the pharma industry to seek technologies that can be used to secure a product throughout the supply chain.

More challenges face the pharma packaging industry today than ever before, according to Domino Printing Sciences' global life sciences sector manager.