Apr 16, 2013
By:
Susan Haigney
FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.
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Apr 12, 2013
By:
Susan Haigney
FDA inspections of compounding pharmacies result in FDA-483 citations.
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Apr 12, 2013
By:
Susan Haigney
FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.
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BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
Mar 1, 2013
By:
Susan Haigney
BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
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Nov 5, 2012
By:
Susan Haigney
USP revises labeling requirements for Heparin.
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Sep 11, 2012
By:
Susan Haigney
As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.
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Sep 5, 2012
By:
Susan Haigney
USP Hosts Symposium on Science and Standards
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Aug 9, 2012
By:
Susan Haigney
The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.
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