QbD in API Manufacturing
With a quality-by-design approach, robust processes consistently can help deliver quality product.

Exploring Newly Introduced Methods for Testing MDIs with Add-On Devices
The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

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Data Integrity Key to GMP Compliance
FDA demands accurate manufacturing and test information to ensure product quality.

Thomson Reuters Projects Pharma Sales Will Reach $1 Trillion in 2014
The Reuters Annual Pharmaceutical Factbook reveals positive outlook for pharmaceutical industry and key insights into current trends.

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FDA Approves XTANDI Capsules for Prostate Cancer
FDA approved XTANDI for the treatment of metastatic castration-resistant prostate cancer.

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Generic Pharmaceutical Association Reports Record Cost Savings
A GPhA report says generic drugs saved the US health system $239 billion in 2013.

FDA Approves Treatment for Children with Hemophilia B
FDA approved Baxter International's treatment, RIXUBIS, for the treatment of children with hemophilia B.

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EYLEA Receives FDA Breakthrough Therapy Designation
Regeneron Pharmaceuticals' injection for diabetic retinopathy in patients with diabetic macular edema received FDA breakthrough therapy designation on Sept. 16, 2014.

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FDA Publishes Additional Guidance on Refuse-to-Receive Standards
FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.

Molecular Profiles Expands Capsule Capability
Molecular Profiles has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the United Kingdom.