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Warning Letters Galore
By Martin Lush, NSF-DBA
Published May 4, 2012
Causes and prevention: What can we learn from the mistakes of others? Read More »
Packaging Trends and Anti-counterfeiting Initiatives
By Kristin Brooks
Published April 4, 2012
Contract packagers and suppliers see opportunities Read More »
Published April 3, 2012
Toride site adds cold chain capability to Japan portfolio Read More »
Rethink Training
By Ellen Leinfuss, Kaplan EduNeering
Published March 7, 2012
Four reasons your FDA compliance training isn’t preventing violations — and how you can change that Read More »
By Kristin Brooks, Associate Editor
Published March 7, 2012
Industry perspective from suppliers and manufacturers Read More »
Published February 13, 2012
No 483 observations issued Read More »
Published February 2, 2012
Site deemed competent and proficient in the safe handling of potent APIs Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March Read More »
Harmonized Tariff Schedule Classification
By Robert E. Schwartz
Published January 23, 2012
Importation of Organic Chemicals into the U.S. Read More »
Published January 23, 2012
Confirms IMP/GMP compliance at Craigavon, Elvingston sites Read More »
The Glass Quandary
By Fran DeGrazio and Diane Paskiet
Published January 23, 2012
Glass breakage, delamination and compatibility with biologics have boosted interest in novel materials in pharma packaging Read More »
GDUFA and CMOs
By Gil Roth
Published January 23, 2012
Will a new user fee affect CMOs and API suppliers? Read More »
Published January 20, 2012
FDA completes review with no 483 citations Read More »
Published January 18, 2012
Expands range of projects for Holywell facility Read More »
By Gil Roth
Published January 17, 2012
Elder leaves agency after more than two decades Read More »
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