Quality Systems

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

The US Pharmacopeial Convention recently held its convention in Washington, DC.

An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.

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

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

FDA Issues Warning Letters to Six US Medical Spas; and More.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

Collaboration has been key to the pharmacopeia's achievement.

Tablets and capsules are mainstay product forms, so what are the spending and innovation trends for solid-dosage manufacturing equipment and machinery?

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

As demand for global vaccine development and production grows, all eyes are turning to Asia.

FDA lacks resources to manage expanding postmarketing responsibilities.

New information improves an organization's guide to building manufacturing facilities.

In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.

The US Government Accountability Office issued a report that's largely critical of FDA's efforts to fully use practices for effective strategic planning and management.

WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.

The European Medicines Agency's Management Board praised the European medicines regulatory network's handling of the 2009 H1N1 swine-flu pandemic.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.

FDA issued a final rule to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

FDA Issues Safety Warning Regarding Zocor; And More.