Minimizing Variation in Vial Withdrawal Practice
Innovations in drug delivery such as needle-free transfer devices and vial adapters can provide consistency when transferring liquid for reconstitution of lyophilized drug products.

Using Quality by Design to Develop Robust Chromatographic Methods
The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

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Investigation of Various Impurities in Febuxostat
Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature.

Salix Looks to Actavis After Terminating Cosmo Deal
New rules from the Treasury Department regarding inversion affect merger activity in the pharmaceutical sector.

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Hospira's Australian Manufacturing Plant Receives FDA Warning Letter
Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.

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FDA Releases Guidance on OTC Pediatric Drug Products
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

Making ZMapp: Production of Experimental Drug to Treat Ebola Is Now A Priority
Manufacturing drugs from biological sources sometimes can't be rushed, even when a rare disease becomes more widespread.

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Sigma-Aldrich Acquires Cell Marque
Sigma-Aldrich has reached an acquisition agreement with Cell Marque to further their antibody portfolio.

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BD Plans to Acquire CareFusion for $12.2 Billion USD
BD announces agreement to acquire CareFusion to further medication management and patient safety solutions.

FDA Releases Guidance on Critical Path Innovation Meetings
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

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New Tax Rules May Deter Future Pharma M&A
Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

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FDA Releases Q&A on DQSA
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

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