Quality Systems

We never thought implementing complex changes could become more cumbersome.

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

Although representing a huge market, the EU also presents problems that hamper profitability- particularly when it comes to differing price regulations across member states.

Pharma faces imminent expiries of key patents and increasing competition from generics. To protect what they already have, or what they will invent or acquire, companies must give patent protection the attention it deserves.

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

New York Governor Wants Stricter Limits On Pharmaceutical Marketing; And More.

Two US senators have introduced the Nanotechnology Safety Act of 2010, which would establish a program within the US Food and Drug Administration to assess the health and safety implications of nanotechnology in everyday products.

Keiji Fukuda, special adviser on pandemic influenza to the World Health Organization's (WHO) director-general, told a hearing at the Council of Europe that WHO's response to the influenza (H1N1) pandemic was not improperly influenced by the pharmaceutical industry.

The European Medicines Agency has launched a public consultation on its Road Map to 2015, a strategic vision that lays out the agency's priorities for the next five years.

FDA Issues Warning Letter To McNeil Healthcare; Charles River Laboratories Will Suspend Operations At Massachusetts Facility.

McNeil Consumer Healthcare is voluntarily recalling certain lots of over-the-counter products in the Americas, the United Arab Emirates, and Fiji.

The United States Pharmacopeial Convention is recalling USP 33?NF 28.

The European Commission has asked certain pharmaceutical companies to submit copies of their patent-settlement agreements.

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.

Bioject Medical Technologies establishes alliance with MPI Research; Biogen Idec CEO to retire; And More.

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.

Team leaders in FDA's Office of Generic Drugs provide an overview.

Plus, novel dosage forms and emerging trends.

Directors and staff miss the mark when it comes to following procedures.

This month sees Europe make its move towards electronic submissions harmonization, but is it ready?

The free movement of goods across Europe might be beneficial for some, but for pharmaceutical companies, the parallel trade of medicines is not welcomed, and is viewed as a system that can damage patient safety and innovation

BioNanomatrix (Philadelphia) names Edward Erickson president and CEO; and More.

Fraud and abuse in healthcare costs individual governments as much as $23 billion a year, according to estimates from the World Health Organization (WHO).

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

Do advanced therapies represent medical miracles or risky business? This is the question that is debated by an Informa analyst in an Executive Briefing for Scrip.

The US Pharmacopeial Convention posted a proposed revised standard for what should and should not appear on the ferrules and cap overseals of medication vials.

Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.

Representatives to the PIC/S provide an example of methodology for implementing ICH Q9.

Dumbed-down presentations and poor speaker selections are destroying a valuable industry tool.

With so many healthcare and pharmacy websites, consumers could use the agency's nod of support.