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Published October 14, 2014
Will undertake a regulatory document inventory and evaluation of Provectus’ information management system Read More »
Published August 5, 2014
Ireland facility gains pre-approval Read More »
Published July 22, 2014
Will produce NME for U.S. market Read More »
Published July 8, 2014
Inspection covered quality system and lab facilities in Torrance, CA Read More »
Published April 30, 2014
Analytical and stability testing, and CTM services deemed compliant Read More »
Published April 24, 2014
Employs Novozymes' VELTIS technology for optimized dosing Read More »
FDA Aseptic Inspections Will Focus on Process, FDA’s Friedman Says
Published March 27, 2014
At a PDA conference track at Interphex 2014, FDA’s Richard Friedman, Associate DirectorAssociate Director of FDA’s Office of Manufacturing and Product Quality at the Center for Drug Evaluation and Research’s Office of Compliance, discussed changes in the way FDA inspectors will review aseptic facilities. The emphasis now, he says, will be on day to day process operations and control. 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 Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »

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