Articles by Susan Haigney - BioPharm International

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Articles by Susan Haigney

The Lifecycle Change of Process Validation and Analytical Testing

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
Mar 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

USP Changes Heparin Labeling Requirement

Nov 5, 2012

USP revises labeling requirements for Heparin.

CDER to Expand Office of Generic Drugs

Sep 11, 2012

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.

USP Hosts Symposium on Science and Standards

Sep 5, 2012

USP Hosts Symposium on Science and Standards

EMA Phases out Follow-Up Measures

Aug 9, 2012

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.

Congress Passes Generic Drug Act

Jul 10, 2012

Congress Passes Generic Drug Act

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

Jul 3, 2012

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

FDA Updates List of Warning Letters

Jun 26, 2012

FDA Updates List of Warning Letters

EMA Makes Orphan Drug Recommendations

Jun 19, 2012

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

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