Navigating FDA Regulatory Meetings
Developing understanding of the best way to productively participate in a regulatory meeting with FDA.

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What Happened to Outsourcing in Asia?
The industry may not be ready for India and China as regulatory issues emerge.

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Extractables and Leachables: Best Practices to Ensure Patient Safety
The author presents best practices for extractables and leachables.

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Kemwell Biopharma Acquires Cirrus Pharmaceuticals Inc.
Kemwell Biopharma announced that it has acquired Cirrus Pharmaceuticals Inc., a contract development services company based in Research Triangle Park, N.C.

Aesica Appoints Chris Gowland as Chief Operating Officer
Aesica has appointed Chris Gowland as Chief Operating Officer, a new position created to further enhance the company’s operational performance in APIs and formulated product-manufacturing services.

Wyeth Fined $490.9 Million for Unlawful Marketing of Rapamune
Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA.

Pfizer to Create Separate Internal Businesses
Pfizer has announced plans to internally separate its commercial operations into three business segments.

Bristol-Myers Squibb and Samsung BioLogics Announce Manufacturing Relationship
Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.

New Modular Vaccine Design Combines Existing Vaccine Technologies
A new method of vaccine design, called the Multiple Antigen Presentation System, may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

FDA Grants Priority Review to Mallinckrodt’s MNK-795
Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.