Quality Systems

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.

Could President Obama's tax reform, which is targeted at reducing outsourcing, endanger India's contract-services industry?

Current methods for establishing visible residue limits (VRLs) are not statistically justifiable. The author proposes a method for estimating VRLs based on logistic regression.

Brief pharmaceutical news items for March 2010.

FDA modernizes information systems, expands access to drug safety and use information.

From last-minute product inserts to putting out fires, close calls are a common occurrence.

Technological developments make it easier to manufacture sterile parenterals.

FDA issues data on drug-induced liver injuries and serious skin reactions; IPEC Federation Week starts in France.

Liquids are used in a wide variety of industries, either during manufacture or as end-products in themselves. Whatever the end product, quality control of liquids is crucial to many industries.

The European Medicines Agency and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.

Margaret Hamburg, commissioner of the US Food and Drug Administration, unveiled a new program to improve the efficiency of import inspections.

EMA statistics highlighting centralized-procedure activities for human medicines show a significant increase in positive opinions made between 2007 and 2009.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Less than a week after president Obama proposed a spending freeze on nonsecurity-related federal programs, the US Food and Drug Administration released its fiscal year 2011 budget request, calling for a 23% increase.

Cephalon Buys Mepha; BASi's CEO Retires; and More.

Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.