All
Abbott Pledges Support for Program to Aid Women and Girls in Burma
August 1st 2012Abbott forms a partnership with the US Secretary of State's International Fund for Women and Girls to support grassroots organizations that are working to advance health, education, and economic opportunity for women in Burma.
EC Investigates Lundbeck for Potential Pay-to-Delay Agreements
July 27th 2012The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram.
AstraZeneca Restructures Vaccines R&D and Operations
July 24th 2012MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.
Product Neutralization for Rapid Microbiological Test Methods
July 18th 2012We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?
Congress Passes Generic Drug Act
July 10th 2012On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.
ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities
July 9th 2012ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen
July 3rd 2012FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.
GSK Agrees to $3 Billion Settlement with Justice Department
July 3rd 2012GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.