Quality Systems

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.

President Obama signed into law major healthcare reform following the passage of the bill by the House of Representatives.

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.

Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.

FDA Issues Warning Letter To Paddock Laboratories; And More.

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

The Pharmaceutical Research and Manufacturers of America, along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes concerning clinical-trial regulation and intellectual property.

Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.

Last week, the US Food and Drug Administration and the National Institutes of Health unveiled plans to establish a Joint Leadership Council to address important public-health issues.

Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.

CMOs' business model has all of the flaws of the captive model it is meant to replace.