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By Kristin Brooks
Published March 6, 2014
Will produce PLacental eXpanded (PLX) cell products Read More »
Published February 19, 2014
13 prequalified companies will participate in program to enhance security of imported drugs Read More »
By Kristin Brooks
Published January 24, 2014
Prohibits manufacture and sale of drug ingredients from Toansa plant Read More »
By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
By Gil Roth
Published September 12, 2013
Ganetespib to help treat adenocarcinoma Read More »
By Gary C. Messplay, J.D., Allison L. Reschovsky, J.D., and Adele M. Kaplan Gilpin, J.D., Ph.D., Hunton & Williams LLP
Published May 30, 2012
A new era of clinical trial transparency enforcement Read More »
By Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »
Published October 21, 2013
Pain treatment uses iCeutica’s SoluMatrix Fine Particle Technology Read More »
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